Director, Clinical Operations Resume Sample
Delpha Waelchi
809 Hayley Course,
Los Angeles,
CA
+1 (555) 391 2394
Work Experience
Director, Clinical Operations
02/2016
-
PRESENT
Houston, TX
- Leadership and management experience, including multi-regional and global focus
- Assists with the development of global, standardized monitoring processes and tools. Approves the processes and tools once final with input from GCOM Director
- Oversees the GCOM communication and tracking tools. Liaises with the appropriate resources to maintain and enhance these tools
- Acts as an escalation point in support of the Business Units and other end users of GCOM tools and processes
- Assists with interviewing and hiring processes of new GCOM associates
- Acts as Monitoring Standard Operating Procedure (SOP) Liaison
- Validates the clinical competencies of the SDC and DNS
- Ensures that training for clinical staff is appropriate to achieve successful performance
- Assists with the orientation of the DNS and SDC
Senior Director, Clinical Operations
01/2009
-
09/2015
New York, NY
- Conducts job responsibilities in accordance with the standards set out in the Company’s Code of Business Conduct, its policies and procedures, the Corporate Compliance Agreement, applicable federal and state laws, and applicable professional standards
- Develops and executes clinical operation plans to meet ClinicalRM’s short and long term government and commercial growth goals
- Provide oversight of multiple clinical programs and evaluate and oversee the activities required to execute, conduct and complete a program, within established timelines and corporate budgets
- Review, track and report staff performance utilizing appropriate tools and reports
- Support the development of clinical operations related Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable
- Track, measure and report the status of program milestones
- Assist in the analysis and reporting of study data (e.g., tables, listings, clinical summary reports, regulatory submission, publications and presentations)
Senior Director Clinical Operations
11/2002
-
11/2008
Detroit, MI
- Assist in the development and implementation of clinical research strategy and manage clinical processes to ensure business goals are met
- Assist with assembly and review of documents for regulatory submissions
- Collaboration on the development of clinical SOPs, Work Practice Guidelines (WPGs) and associated tools
- Periodically review SOPs, WPGs and associated tools for applicability and suggest appropriate modifications
- Develop and periodically evaluate job descriptions for assigned staff
- Ensure clinical operations teams regulatory and Good Clinical Practice (GCP) compliance
- Comply with applicable regulations, GCP and corporate policies and procedures
- Provide CLO expertise and decision-making ability and authority to the CDT (both strategic and operational), ensuring alignment within CLO Sr. Management
Education
Strayer University - Arlington Campus
1997 - 2001
Bachelor's Degree in Nursing
Professional Skills
- Strong prioritization and organizational skills with the ability to manage multiple tasks
- An up-to-date resume which clearly details your skills, experience and key achievements as relevant to this role
- Excellent oral, written, and medical communication skills required
- : Experienced in clinical research, with experience managing Project Managers
- Demonstrated team leadership in a matrix environment. Experience in the direct interaction with Marketing and Legal functions
- Managerial experience demonstrating the ability to manage clinical personal effectively
- Highly developed written, oral, and interpersonal communication skills
How to write Director, Clinical Operations Resume
Director, Clinical Operations role is responsible for clinical, organizational, leadership, interpersonal, analysis, training, finance, integration, database, procurement.
To write great resume for director, clinical operations job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Director, Clinical Operations Resume
The section contact information is important in your director, clinical operations resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Director, Clinical Operations Resume
The section work experience is an essential part of your director, clinical operations resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous director, clinical operations responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular director, clinical operations position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Director, Clinical Operations resume experience can include:
- Facilitate timely and effective communications of CDT decisions and progress to CLO, as well as communicating significant CLO decisions and issues (including those of any functional area sub-teams or committees) back to CDT
- Contribute to the establishment of CDT goals that are aligned with Corporate and Global Clinical Development goals and that SETs and other GCD functional teams are executing to optimally achieve those goals
- Excellent interpersonal skills, with a demonstrated ability to work in a team environment or independently, are required
- Demonstrates project and people managerial skills such as
- Excellent negotiation, conflict resolution, interpersonal, decision-making, and communication skills (oral and written)
- Ensures all necessary training and mentoring is provided to staff to improve their job performance and knowledge, and to effectively succession plan
Education on a Director, Clinical Operations Resume
Make sure to make education a priority on your director, clinical operations resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your director, clinical operations experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Director, Clinical Operations Resume
When listing skills on your director, clinical operations resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical director, clinical operations skills:
- Experience as a Director; or 5+ years’ experience in a senior managerial role
- Prior experience in leading a clinical operations group
- Experience in the healthcare industry preferably in utilization or care management and preferably with health insurance / health plan experience
- Organizing: Ability to organize and prioritize work schedules of others on a long-term basis
- Strategic thinking capability and strong with decision-making
- Experience managing CROs and vendors and monitoring their performance
List of Typical Experience For a Director, Clinical Operations Resume
1
Experience For Senior Director, Clinical Operations Resume
- Effectively manages staff to ensure high performance, continuous development and low turnover
- Responsible for auditing of monitoring and ensuring site recruitment, initiation objectives and patient enrollment targets are met
- Responsible for directing department compliance with Medicare flagging, Sunshine Act reporting, OHRP, ICH, and GCP regulations and guidance’s
- Oversee, train, and mentor all CLO staff contributing to studies supporting the program & CDT
- Assist in developing and overseeing the implementation of CAPA in relation to sponsor’s audit or regulatory inspections
- Participate and contribute in key strategic program planning meetings (such as, advisory board, steering committee), as needed
- Strategic direction and oversight to the following business areas
- Directs staff. Manages initiatives that improve departmental turnover while maintaining high employee and patient satisfaction
- Care coordination includes communicating with ministry market leaders, AMG leaders, community organizations, health plans, facilities, and specialists
2
Experience For Director Clinical Operations Resume
- Ensures timely occurrence reporting and chart completion
- Ensures timely and accurate clinical reporting and monthly closeout of data
- Work in a high stress, constantly changing environment daily
- Ensure appropriate monitoring oversight plans are in place, and reflect adequate adherence to Federal regulations, GCP and SOPs
- In conjunction with SETLs, provide updates to SETs on corporate perspectives and ensure alignment of Corporate and GCD goals
3
Experience For Senior Director Clinical Operations Resume
- Support and enable “Lessons Learned”, as conducted by the CDT, SETs and functional partner teams
- Ensure compliance with GCPs as promulgated by ICH E6 and other relevant local, regional or national regulations regarding clinical study conduct and protection of human subjects
- As a member of the CLO Leadership team, assist the VP, CLO in defining and implementing departmental strategy and mission, including resource and budget management
- Lead and contribute to departmental and cross-functional improvement activities
- Is responsible for the overall direction, coordination, and evaluation of various units
4
Experience For Senior Director Clinical Operations, CCM Resume
- Provide therapeutically focused support and oversight to staff for development and optimization of global clinical strategy and processes, including effective delegation to direct reports to meet program goals
- Support VP, Clinical Operations with implementation of initiatives, serve as liaison / change management champion for Clinical Operations
- Proactively work with clinical teams to develop and assure effective implementation of compound development and study execution plans. Facilitate problem solving and conflict resolution with internal and external stakeholders to prospectively reduce issues / remove roadblocks and keep teams on track with key deliverables across the compound(s)
- Oversee and ensure development of accurate program and study level plans. Actively contribute to the Global Project Team, supporting the strategic planning and execution of clinical development plans, including all governance processes, external consultants, and partnering activities
- Communication Skills- Excellent oral, written communication, and presentation skills utilizing all available technologies
- Collaboration & Teamwork– Advanced competence in collaboration and teamwork
- Has oversight of the Post Acute facilities clinical programs
- Assists the DNS's with planning, developing, organizing, implementing, coordinating and directing the quality assurance and assessment program designed to enhance the quality of resident care, in accordance with current rules, regulations and guidelines that govern Post Acute facilities
- Assists in developing follow-up procedures for monitoring identified problem areas
5
Experience For Director Clinical Operations for Acute Medicine Services Resume
- Coordinates concurrent review studies performed within the quality assurance program, prepare resulting reports as required
- Establishes and maintains tracking systems for recommendations of groups involved in quality assurance
- Develops written and oral reports/recommendations, as necessary/required, concerning the operation of the quality assessment and assurance program
- Evaluates programs and effect changes as necessary to improve programs and assure compliance with regulatory requirements
- Communicates revised plans and changes to facility management to maintain awareness
- Reviews the facility's quality indicators, quality measures and survey reports to assist in identifying potential problem areas; develops and assists with the DNS's corrective action plan as necessary
- Tertiary qualifications in Health Management and/or demonstrated equivalent knowledge, experience and training
- Works with the clinical managers in reviewing policies and procedures, survey reports, to ensure protocols are in place to aid in loss prevention
6
Experience For Director, Clinical Operations, Vaccines Resume
- Assists in training and clinical program development and assist in throughput initiatives
- Participates in and assists with facility surveys
- Assists other committees and departments in the development of monitoring tools, criteria and standards, assessment methodologies, and the evaluation and selection of priority concerns impacting on resident care and safety
- Implements recommendations from the Quality Assessment & Assurance Committee as they relate to the quality assurance program
- Audits MDS process and protocols
- Provide expert operational oversight and guidance supporting in prioritization of activities, review and monitoring the work performed, and development of contingency plans, among others
7
Experience For Senior Director, Clinical Operations CNS Resume
- Manage resource availability in the assigned country or region within the assigned Business Unit; ensuring that projects are suitably resourced and needs to hire new staff are identified in a timely fashion. Manage and
- Establishes quality and performance expectations on an ongoing basis. Maintains awareness of project resourcing issues, hours and overall workloads. Provides regular updates to the assigned Business Unit
- Conduct timely performance reviews and appraisals by acquiring feedback on the manager’s performance from Project Managers, Directors, Clinical Operations and others as required. Ensure that clear goals and objectives are set
- The Director shall facilitate positive effective working relationships with the Governing Body, Medical Director and Medical Staff
- The Director reports to the Chief Operating Officer of the hospital
- Manages study timelines, deadlines and budgets to include negotiating contracts with study vendors, CROs and clinical trial sites/PI’s
- Shall serve as a liaison between the hospital and the physician’s medical practices
- The CNO has direct and indirect responsibility & authority for establishing nursing standards of practice and nursing standards of care in all areas in which nursing care is provided
8
Experience For Director, Clinical Operations, Onkaido Resume
- The Director supervises all clinic employees
- Actively participates as the lead research team member interacting with and providing oversight to assure investigator compliance with the study protocols, regulatory guidelines and company standard operating procedures. Performs the function of Pacira’s face, thought and conscience to the investigative community
- Works with clinical research/operations team and Regulatory Affairs in the preparation of project-related documents and regulatory submissions, including Investigator’s Brochures, Annual Reports, INDs and NDAs
- Proven ability to forge cross-functional working relationships with internal teams . Clinical Trial Sites/PI’s, external contractors, vendors, and customers
- Dedicated line manager for the Monitoring and study start up teams at country level
- Provide effective management support through your management team to deliver a high performing culture including managing attrition, development and engagement of the operational group
- Leading and managing the local clinical operations management team by empowering and coaching them to deliver their key objectives
- Carrying out all relevant line management responsibilities including appraisals, goal setting and development plans
- Accountability and responsibility for corporate clinical outcomes reporting and working in partnership with VP’s and center teams for specific center process improvement
9
Experience For Regional Director, Clinical Operations Resume
- Direct and provide ongoing education support at the facility level
- Support training in the clinical aspects of patient education and quality outcomes for management as needed
- Benchmark centers’ outcomes; identify and share best practices
- Ensure new clinical teammates complete the appropriate clinical training programs required including but not limited to DaVita Prep training program, skills checklists, clinical hours, and other training initiatives
- Identify specific training needs within the Lifeline and outside Lifeline within the provider community and implement action plans to meet those
- Assist in corporate and/or division initiatives and special projects as assigned
- Leads Global Clinical Operations, Development Operations or TDC initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives
- Expedites ICC Program Maturation by achieving and reaching Intensivist Program developmental milestones – by in-servicing ICU nursing staff in ICC protocols – ultimately improving LOS, ICU Mortality Rate.
10
Experience For Director Clinical Operations Cancer Institute Resume
- Improved compliance with key protocols including Sepsis Protocol, Sedation and Analgesia Protocol, Extubation Protocol, Glycemic Control and Early Mobilization Protocol – Improving sepsis Mortality Rate, vent days and ICU complication Rate.
- Communicate effectively with all other departments to accomplish common goals
- Improving nursing and physician clinical documentation - DRG accuracy/ CMI, CPT Coding.
- Facilitated Process of Streamlining patient care plan – improving patient/ family satisfaction
- Design, update and implement appropriate innovative and best-in-class procedures and SOP’s related to clinical study planning and execution, in collaboration with relevant functions
- Organizes and leads implementation of operations to provide high quality, cost effective services. Models leadership and teaming excellence by providing appropriate advice and counsel to staff to improve effectiveness
- Develops and implements policies and procedures that support the delivery of services to meet all performance plans
- Coordinates and integrates services to meet contractual requirements. Conducts ongoing assessments, maintains quality control programs, and improves clinical operations
List of Typical Skills For a Director, Clinical Operations Resume
1
Skills For Senior Director, Clinical Operations Resume
- Oversee direction, guidance, training and support provided by regional support teams. Develop team goals and objectives, coordinates activities of team members and provides status reports to senior management
- Overall control of planning, staffing, budgeting, managing expense priorities and recommend and implement changes to current methods
- Experience in building and managing budgets, including collaboration with and across different functional areas is required
- Experience in billing and coding practices
- Experience being a member of cross-functional teams
- Experience in managing CROs and vendors
- Knowledge and understanding of Good Clinical Practices (GCP) and other Clinical Trials Regulations and guidelines
2
Skills For Director Clinical Operations Resume
- Extensive experience managing clinical programs, budgets, and timelines required
- Experience handling trials with in oncology/hematology
- Reasoning and Decision Making: Ability to make decisions which have significant impact on the Company’s reputation, credibility, operations and services
- Working knowledge of clinical quality metrics such as HEDIS, NCQA or National Quality Forum type metrics
- Understanding of drug development and program management from pre-IND through NDA is essential
- Responsibilities include interviewing, hiring, and training employees in the clinical group; planning, assigning, and directing work
3
Skills For Senior Director Clinical Operations Resume
- Create & implement operational trial plan with team & management; support, including tracking & updating as required
- Knowledge of the Nurse Practice Act, state and federal regulations and Kindred policies and procedures regarding nursing standards and delivery of care
- Collaborates with leadership staff to assist with department planning and setting performance goals
- Analyze of clinical data, including safety monitoring and drug safety
- A cover letter responding to the targeted questions below
- Evaluate adequacy of standard operating procedures and processes and if needed develop additional ones
- Develop study documentation. Overall responsibility for consistency and accuracy of trial information in databases and tracking systems
- Regional interface on behalf of GSK CH with external organizations including clinical research professional organizations and policy makers
- People Management – Ability to direct the day-to-day work of others and the ability to recruit, develop and retain high performing employees
4
Skills For Senior Director Clinical Operations, CCM Resume
- Hear what clients are saying in a normal conversation
- When not traveling maintain in-office, regular work hours to facilitate interactions with other employees
- Provides oversight of CROs using relevant metrics and tools and monitors progress toward Clinical Operations objectives
- Responsible for archiving of trial master files and other clinical trial documents in compliance with applicable guidelines and regulations
- Advanced understanding of the pathophysiology of brain death and methods to ameliorate those effects on transplantable organs
- Collaborates with transplant teams and others by proposing research projects to improve organ donation and transplantation
- Oversight of the operational planning and execution of Ph I-IV trials across therapeutic area portfolio
- Mentor and develop Clinical Trial Managers and Associates to expand employee performance levels and assure retention of high performing individuals
- Develop and maintain departmental standard operating procedures (SOPs) in collaboration with Clinical Development, Regulatory Affairs and Quality Assurance
5
Skills For Director Clinical Operations for Acute Medicine Services Resume
- Attend seminars, Investigator meetings, project team meetings, educational conferences/training sessions, etc
- Oversees the development and ongoing operation of the Evolent Health Care Management and overall clinical operations for our clients
- Create and implement mitigation strategies, identifying program risks
- Collaborate with Medical Writing Department in the preparation of clinical development plans
- Communicate protocol information, including changes or amendments to trial sites
- Develop trial level operational training materials for Clinical Team, Field Monitor, and Trial Sites
6
Skills For Director, Clinical Operations, Vaccines Resume
- Responsible for 4-6 direct reporting Clinical Services Managers with approximately 50 indirect reports
- Contribute to strategic planning to ensure optimized clinical development plans for assigned projects
- Build, manage, and cultivate high performing clinical teams
- Work independently in an interdisciplinary, fast-paced, often changing environment
- Participate in the budget process to recommend appropriate resource allocation for support activities.
- Direct staff to facilitate operational training including systems and orientation to position for clinical as well as non-clinical staff. Facilitate communication and information flows between Support Center and the field organizations
7
Skills For Senior Director, Clinical Operations CNS Resume
- Work with senior management to identify opportunities for growth and plan specific actions to support same
- Participate in the development and coordinates the implementation of comprehensive internal clinical auditing procedures in the region. Participate in meetings with internal departments to gather information and ensure that the audit/assessment tool (s) continue to measure critical indicators of success and address company objectives
- Oversee regular (at least annual) comprehensive on-site assessment of all home health and hospice offices including administrative, operational, human resources and clinical care
- Communicate audit results/trends to regional/senior management and applicable support center departments. Make recommendations for revisions in policy/education/training. Review and prepare written reports to communicate observations and recommendations
- Travel to branch sites to evaluate and assist operations support staff. Provide guidance, direction and interpretation of policies to line management and field staff on matters affecting delivery of service
- Facilitate compliance to company policies and legal requirements and reports findings that would put the company at risk to senior management, the Director of Compliance the Legal Department and the Chief Compliance Officer, as indicated
8
Skills For Director, Clinical Operations, Onkaido Resume
- Drive compliance with local, state and federal regulations and accreditation requirements as applicable. Participate in management interviewing and orientation
- Drive improvement in efficient provision of care, promoting protection and improvement in patient outcomes. Assist staff and line management in determining appropriate actions to take in appropriately managing utilization of resources in providing patient care
- Directs team/participates in development of training materials as needed and as available to ensure appropriate orientation and education of support, line, office and caregiver staff
- Attend courses/seminars/workshops and reviews industry publications. Keep abreast of regulatory policies and trends. Educate Regional Vice Presidents and senior managers on industry trends, and Clinical Operations products and protocols
- Leadership (40%): management responsibility over the clinical team (clinical scientists, managers), including hiring, performance management, talent planning, coaching, training (clinical methodology training, clinical methodology development), cross-department activities
9
Skills For Regional Director, Clinical Operations Resume
- Problem solving (20%): provide action plan when desired outcome not reached, including in-depth diagnostic and analysis
- Independence of action and accountability (10%): sets direction and vision for the clinical team at large (including matrixed sub-functions)
- Budget responsibility (10%): manage a $6-10MM clinical budget between in-house and external studies
- Manages assigned portfolio of Health System operated outpatient clinics. Oversees the operational and financial performance of assigned clinics in coordination with department leadership and/or governance committees. Establishes a clinic operating model that is both efficient and leads to high-quality patient outcomes
- Assists in developing and implementing strategies to improve operational processes and productivity. Monitors development of specifications and establishes priorities. Presents data and program information
- Nterpret, explain, and discuss data analysis results with project teams. Makes recommendations and support strategies for improving clinical processes and patient outcomes including management of patient responsiveness, call triage, documentation of care, wait times, and care management
- Direct management of Clinical Program Managers and Clinical Operations Manager(s) (who manage clinical study managers)
- The Director of Clinical Operations manages the financial and clinical operations of the RN house supervisors, nursing operations, RN float pool, bed managers, and staffing coordinator
10
Skills For Director Clinical Operations Cancer Institute Resume
- Integrates department services with the hospital’s primary function. Coordinates and integrates services within departments. Develops and implements policies and procedures that guide and support provisions of services
- Supervises nursing staff and assures staff competency. Develops, markets, implements, and evaluates new services and programs. Participates in outside source selection for needed services
- Capable of formulating a clinical project plan based upon literature, input from internal and external experts, and own experience
- Strong GCP and regulatory knowledge including FDA, ISO and ICH regulations
- Assess the inherent risks of a situation, their potential impact on a project and based on this information, independently make timely decisions
- Manage vendor/contracts relationships
List of Typical Responsibilities For a Director, Clinical Operations Resume
1
Responsibilities For Senior Director, Clinical Operations Resume
- Excellent teamwork and collaboration skills. Attention to detail required
- Proven track record in development and management of SOPs, processes and developing effective metrics systems is required
- Demonstrated experience in leading a complex matrix organization with senior internal stakeholder interfaces
- Proven experience in the oversight of the operational aspects of all stages of clinical studies
- Direct the management and maintain strong, effective relationships with vendors, consultants, investigators, and other external clinical trial participants
- Within the 8 years of applicable experience, preference is for at least 4 of the years to be device experience
2
Responsibilities For Director Clinical Operations Resume
- Demonstrated ability to attend to details, prioritize and complete multiple tasks independently
- Provide expert operational oversight and guidance supporting in prioritization of activities, review and
- Extensive experience in clinical testing (at least 10 yrs) in the skin care category (at least 5 yrs)
- Sets strategy for the effective operational management of future clinical trials
- Set strategy for the effective operational management of future clinical trials
- Build strong KOL and Principal Investigator relationships, with the ability to easily understand and explain complex scientific topics
- Organize and manage multiple priorities required
3
Responsibilities For Senior Director Clinical Operations Resume
- Represent Receptos in a professional manner; establish and maintain good relationships with Investigators, advisors, other study personnel, clients and vendors
- Computer literacy (Word/Excel), familiarity with clinical database concepts, and experience with statistical principles is required
- Experience in a Director or Management role in Clinical Operations
- Demonstrated ability to conduct, manage and lead clinical trial projects
- Provide direct operational input into protocol development to ensure efficient and effective delivery of trial objectives
4
Responsibilities For Senior Director Clinical Operations, CCM Resume
- Reviews invoices from sites, CROs and third-party vendors to ensure work has been completed satisfactorily prior to payment
- Develops and manages departmental budgets and ensures appropriate resources and priorities are maintained
- Related experience in the pharmaceutical or biotechnology
- Line management experience
- Experience with electronic medical records and information
- Leads global activities associated with the execution of clinical studies including investigator selection, monitoring, data collection and management
- Manages DSMB/CECs, including member identification/qualification, meeting preparation, management, and follow-up, as needed
- Provides troubleshooting and creative problem-solving leadership to the department
5
Responsibilities For Director Clinical Operations for Acute Medicine Services Resume
- Advanced knowledge of clinical research financial parameters and project financial tracking and accounting methods
- Hires, trains and directs staff from the complex case management, health coaching, physical and behavioral condition management teams
- Provides support to sales and marketing efforts as needed
- Manage resource availability in the assigned country or region within the assigned Business Unit; ensuring
- Leads the development and implementation of policies, procedures and strategies
- Works collaboratively with department leadership for operation of the departments, other operational aspects related to contracting and maintains contracts with key stakeholders
- Identifies marketing and collaborative opportunities for the department
- 3) Provides support and/or clinical oversight of special projects (i.e., Flu Vaccine Blitz, prematriculation requirement program, pre-participation physical exams for student-athletes, TB testing of international students, etc.). Oversees public health reporting to relevant local and state partners. (5%)
6
Responsibilities For Director, Clinical Operations, Vaccines Resume
- Develops and executes clinical operation plans to meet ClinicalRM’s short and long-term government and commercial growth goals
- Ensures that clinical trial projects are properly resourced, managed and executed within contractual agreement and budget and in accordance with established timelines and quality standards
- Responsible for the identification of areas for process improvement and for the development and deployment of enterprise project controls tools, methodologies, and systems
- Manages the day-to-day clinical operations, including management of vendors (e.g., CRO) and coordination of activities, and identification of and mitigation of project risk
- Proactively tracks and manages leading performance indicators to ensure the high-quality, timely, and cost-effective execution of ClinicalRM contracts and clinical trials
- Maintains proper communications with other departments to ensure communication and good relationships about matters related to clinical trial projects
- Member of cross-functional teams representing Clinical Operations
- Lead the Clinical Operations team
- Leads the efforts to develop and refine processes to govern all Clinical Operations and CRO activities including operational systems and related SOPs, including study planning, selection of study sites and investigators, the conduct of clinical trials and data management
7
Responsibilities For Senior Director, Clinical Operations CNS Resume
- Works with Technical Development and Quality group to oversee the packaging, labeling and distribution of study drug supply from manufacturer to study sites
- Develops and implements risk evaluation and mitigation processes
- Maintains and ensures current expertise in clinical study operations, ICH/GCP Guidelines and FDA or other regulations
- Accountable for the conduct of clinical trials in compliance with GCP and all relevant regulations, policies, and ethical standards
- Takes initiative to help find solutions to clinical trial issues for his/her staff, yet understands the importance and role of the cross-functional matrix team
- Collaborates with functional managers to assure integration of project, company, and functional goals towards achieving clinical project milestones and timetables
8
Responsibilities For Director, Clinical Operations, Onkaido Resume
- Builds partnerships and a positive team-based culture; communicates with organization in a clear, open, balanced and objective manner
- Communicates the progress, cost, technical risk and key issues of clinical trial programs
- Provides mentorship to direct reports and maintains clear communication on performance to direct reports
- Serves as a Clinical Project Manager and lead study teams, as needed
- Assists in the development of clinical submissions to FDA and other regulatory authorities, if applicable
9
Responsibilities For Regional Director, Clinical Operations Resume
- Mastery of the science and practice of all aspects of the organ and tissue donation process
- Build and mentor a cohesive, multidisciplinary expert clinical team of organ and tissue procurement coordinators and technicians
- Communicate complex clinical information in a concise manner
- Implement change in a positive manner
- Develop and maintain trust-based relationships
10
Responsibilities For Director Clinical Operations Cancer Institute Resume
- Understand and utilize clinical organ and tissue recovery data to identify and implement strategies to increase the number and viability of transplantable organs and tissues
- Anticipate potential changes in the national organ and tissue donation regulatory environment and position TransLife to adapt and comply with these changes in the time frames identified
- Utilize the principles of quality assessment and performance improvement as it pertains to the clinical organ and tissue procurement environment to create strategies to increase availability
- Analyze clinical organ and tissue recovery program financial data and create efficiencies that positively impact the availability and condition of transplantable organs and tissues
- Extensive knowledge of utilizing and generating reports from the major organ and tissue procurement industry information technology platforms such as Statline and iTransplant
- Extensive knowledge utilizing DonorNet, the OPTN’s national centralized IT platform to facilitate safe and effective organ allocation
- Knowledge of federal and state regulations and OPTN policies to ensure compliance with national performance expectations and goals
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