Manager, Clinical Operations Resume Sample
Jett Moore
6415 Shaina Key,
Dallas,
TX
+1 (555) 364 0410
Work Experience
Manager, Clinical Operations
08/2015
-
PRESENT
Los Angeles, CA
- Support Study Lead on any delegated cross-functional activities
- Train and mentor junior regional team members such as CRAs and CTAs
- Prepare regional standard metrics (KPIs, SQMs) for global study dashboards to routinely monitor team activities and ensure compliance to timelines, quality and budget
- Provide forecast for regional clinical supply, including ancillary supplies and comparator drugs
- Ensure compliance with regional regulations, GCP, and SOPs during the execution of the study
- Contribute expertise to departmental and cross-functional process improvement activities
- Partners with Medical Research and other functions to
- Able to influence MD on clinical study/program direction based on changing internal and external landscapes within phase, disease or therapeutic area; able to think strategically to best position a study within the current Clinical Development Plan
Senior Manager, Clinical Operations
05/2008
-
02/2015
San Francisco, CA
- Maintain the special nature of the patient-physician relationship
- Unequivocal excellence in all aspects of the organization
- Treat others as we would like to be treated
- Oversee, train and mentor junior study team CRAs and CTAs on study
- Prepare and communicate study dashboards of standard metrics (KPIs, SQMs) to routinely monitor team activities and ensure compliance to timelines, quality and budget
- Manage protocol deviation reviews in collaboration with CLS
- Provide forecast for clinical supply, including ancillary supplies and comparator drugs
- Oversee TMF maintenance
Associate Manager, Clinical Operations
03/2003
-
04/2008
Boston, MA
- Related experience in (conducting) clinical studies (healthcare setting, CRO, medical device and/or pharmaceutical company and/or industry)
- Executes specific departmental goals, standards, and objectives which directly support the strategic plan and vision of the organization
- Manages staff relations including performance management, staff satisfaction, and conflict management. Performs and oversees scheduling, recruitment, payroll, and student engagements
- Adheres to departmental budgets, regulatory compliance, departmental contracts, and vendor relations. Determines and justifies needs for systems, equipment, and supplies purchases; monitors usage and oversees proper working order and stock supplies
- Adheres to quality standards and goals for patient care delivered and coordinates patient care services with patients, staff, physicians, and other departments
- Participate in and/or champion the implementation of PAREXEL and department system/standards improvement activities
- Demonstrate leadership within department, function or location. This includes taking an active role in departmental, functional or location activities
Education
West Coast University
1999 - 2003
Bachelor's Degree in Nursing
Professional Skills
- Teaching, mentoring and presentation skills and experience
- Self-Starter with strong critical thinking skills
- Demonstrated leadership ability with effective communication, motivational and critical thinking skills
- Excellent management skills, developed with a collaborative approach to driving performance and success in a global environment
- : Experience in clinical research, with at least 2 years’ experience managing others; CRO/Pharma experience required
- Excellent organizational, analytical, leadership, problem solving, written/verbal communication, computer and interpersonal skills required
- Strong organizational, communication and mature interpersonal skills
How to write Manager, Clinical Operations Resume
Manager, Clinical Operations role is responsible for interpersonal, computer, leadership, organizational, excel, healthcare, communications, english, collaboration, health.
To write great resume for manager, clinical operations job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Manager, Clinical Operations Resume
The section contact information is important in your manager, 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 Manager, Clinical Operations Resume
The section work experience is an essential part of your manager, 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 manager, 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 manager, clinical operations position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Manager, Clinical Operations resume experience can include:
- Effectively manage aspects of multiple studies and/or programs at one time, with good prioritization and time management skills
- Identifies and communicates the skills, behaviors and experiences required to develop employees
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative and fast-paced work environment
- Experience in the pharmaceutical industry including direct experience in managing successful teams is required
- Selecting the study sites and strategically building strong relationships with investigators and investigational site staff
- Experience developing policies, procedures and systems related to finance and accounting practices
Education on a Manager, Clinical Operations Resume
Make sure to make education a priority on your manager, 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 manager, 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 Manager, Clinical Operations Resume
When listing skills on your manager, 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 manager, clinical operations skills:
- Demonstrated ability to effectively manage several priorities simultaneously in a fast paced, changing environment
- Solid computer skills – requirement of MS applications including (but not limited to),Word, Excel
- Prioritize effectively and respond to urgent requests within team or from sponsor
- Excellent organizational, communication (verbal and written), and interpersonal skills
- Work independently, prioritize and function effectively within a matrix team environment
- Excellent verbal, written, communication, presentation, and facilitation skills
List of Typical Experience For a Manager, Clinical Operations Resume
1
Experience For Senior Manager, Clinical Operations Resume
- Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated team
- Prior experience developing and executing a work plan or strategic plan is needed
- Highly developed leadership skills to successfully lead a clinical study team
- Comfortable in a fast-paced small company environment and able to adjust workload and responsibilities based upon changing priorities
- Previous experience of working in a global company
- Good understanding of clinical study implementation process
- Ensure all audit requests, responses, and effectiveness checks are supported, addressed and closed according to jointly agreed timelines
2
Experience For Manager Clinical Operations Resume
- Related oncology clinical trial management experience
- Significant oncology clinical trial management experience
- Excellent knowledge of GCP compliance issues
- Collaborates with the Director of Clinical Operations and medical affairs staff as needed to maintain good information flow and operational efficiency
- Working knowledge and understanding of the science of the therapeutic area
3
Experience For Associate Manager, Clinical Operations Resume
- Working knowledge of the budgeting process and budget management
- Developing study operational strategy and risk mitigation plans in alignment with the clinical development plan and program operations strategy
- Detailed understanding of the contracting process, including relevant terms and conditions
- Support efforts for generating business leads (client networking, public speaking, etc.)
- Provides assistance to the Senior Nursing Leadership team in the monitoring and management of the Ambulatory Nursing Administration budgets
- Assists in developing and executing clinical operation plans to meet ICON GPHS’s short and long-term government and commercial growth goals
- Works with the director to ensure that assigned clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards
- Extensive contractual and financial management experience, including working with finance, legal and compliance professionals
- Experience developing and negotiating contracts and agreements
4
Experience For Senior Manager, Clinical Operations Lead Resume
- Manage and oversee team activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of project deliverables
- Ensure global process and procedures for clinical study execution are followed and gaps in understanding addressed through regular training
- Responsible for training external and/or internal personnel working on clinical programs
- Serve as an ongoing liaison with Project Team, Sponsor and management regarding performance of direct reports
- Capable of handling (assimilating) in-depth technical information from a variety of disciplines in order to be scientifically credible within the global team
- Active Coding Certificate or active Nursing license (RN)
- Leads and promotes staff engagement in decision-making using the Shared Governance model
- Knowledgeable in federal and state laws governing privacy, confidentiality, duty-to-warn, child and elder abuse reporting requirements
5
Experience For RTS Manager, Clinical Operations Resume
- Manages the day-to-day clinical operations of assigned projects/studies, including management of vendors (e.g., CRO) and coordination of activities
- Responsible for assisting, when applicable, in the development of effective PMO program/project tools to aid in process standardization (project audits, reports, templates, knowledge management tools such as a “Lessons Learned” library, and intranet)
- Assists with proactively tracking and managing leading performance indicators to ensure the high-quality, timely, and cost-effective execution of ICON GPHS’s contracts and clinical trials
- Selects/approves monitoring CROs and study sites
- Collects and reviews key monitoring processes to be benchmarked, tracked and analyzed
- Where appropriate, take appropriate action following regular feedback
- Oversee day - to - day operation of Oncology to include scheduling of patient, physician and treatment visits
6
Experience For Study Manager, Clinical Operations Resume
- Define and implement the sourcing strategy for the study
- Develop relationships within the insurance industry to explore financial models for reimbursement of services utilizing Colgate products
- Execute contracting strategy in compliance with approved department’s budget
- Complete and oversee all quality audit reviews, including rebuttal processes and escalations
- Manages work allocation, training, compliance with internal procedures and controls and problem resolution
- Present metrics to leaders including action items, and implementation strategies based on data. Analyze for cause and effect for impact
- Collaborate with our client and IQVIA team on resourcing and retention areas (e.g. forms and tools linked to operational activities)
- Interacts with care managers in reviewing cases and utilization patterns, and organizes doctor rounds schedules and case presentations
- Manages issues and provides follow up for action items requiring resolution
7
Experience For Associate / Manager, Clinical Operations Resume
- Coordinate and evaluate external outsourcing for projects, proposals, and selection of external project vendors and recruitment of investigators
- Support new and ongoing clinical trials to ensure successful completion of programs
- Responsible for putting in place confidentiality agreements and clinical agreements to ensure efficient and timely completion of projects
- Responsible for project financial forecasts and tracking
- Proficiency in data collection design, scientific evaluation and clinical planning
- Current Nursing licensure in Illinois
- Travel, including international travel
- In the healthcare field, with an emphasis in clinic operations or staff training and development; Utilization Review, care & transition management
8
Experience For Business Change Manager, Clinical Operations Resume
- Active Coding Certificate (i.e.: CPC, CPCC and/or APC, etc)
- Active Coding Certificate (i.e.: CPC, CPCC and/or APC, etc.)
- Sound knowledge of HIPAA regulations governing patient privacy and ensures staff adheres to regulations
- Knowledge of office workflow and processes; and the principles of Continuous Quality Improvement (CQI) and problem solving techniques
- Knowledge of medical coding systems (i.e., CPT, ICD-9/10, revenue codes)
- Work collegially with health care professionals, including physicians
- Three years managing teams in a complex work environment
- Knowledgeable of accrediting body and regulatory guidelines
- Manage the relationship with clinical study site staff, including investigators, study coordinators, pharmacists, as well as other relevant functions
9
Experience For Senior Associate Manager, Clinical Operations Resume
- Maintains proper communications with other departments to ensure a cohesive and collaborative team approach
- Cultivates a strong and transparent working relationship within Clinical Operations and ensures open communication by targeting financial, programmatic, and impact performance against stated milestones and goals
- Has primary accountability for operational study level time, cost and quality deliverables
- Manages overall study budget – for large, global or multiple regional studies. Coordinates all operational clinical research activities for regional/global studies
- Manages all aspects of study progress from start-up to close-out activities in accordance with ICH/ GCP guidelines
10
Experience For Senior Manager Clinical Operations / COM Resume
- Contributes to preparation of teams and documents for inspections
- Assesses risks and develops creative solutions
- Escalates issues to Unit leadership as appropriate
- Comprehensively assesses options to address study issues
- Supports the timely development and/or review of all study related documents (e.g., PCS, Protocol, CRF etc.) and operational feasibility assessments
List of Typical Skills For a Manager, Clinical Operations Resume
1
Skills For Senior Manager, Clinical Operations Resume
- Excellent organizational and interpersonal skills, as well as written and verbal communications skills
- Strong written and verbal communication skills including good command of English
- Effective time management skills and ability to manage competing priorities
- Demonstrated good customer service skills with the ability to listen and convey ideas and information in both verbal and written format
- Scientifically and clinically astute with very strong project management skills
- Strong communication, organizational, and interpersonal skills are required
- Prior experience with payment validation
- Excellent organizational and problem solving skills
- Demonstrated interpersonal relationship skills
2
Skills For Manager Clinical Operations Resume
- Proven manager skills are required
- Strong operations and project management skills with minimal supervision
- The ability to motivate and train adults. Skills in tracking, trending, monitoring and reporting
- A proven track record of success with both individual and collaborative problem-solving, showing demonstrable evidence of sound judgment and decision-making
- Demonstrated study site monitoring, and study leader/management experience
3
Skills For Associate Manager, Clinical Operations Resume
- Support staff to improve their efficiency and effectiveness at prioritizing
- Confident decision-making and ability to work effectively as a team leader, team member, or individually
- Train operations staff and verify they are aligned with SOP’s and Skills checks
- Experience in line management and knowledgeable of Good Clinical Practices
- Good ability to lead, collaborate and build effective relationships (including cross-functionally) with co-workers, managers, and customers
- Prior global/multi region trial management experience is required
- Fluent written and spoken language skills in Finnish and in English
4
Skills For Senior Manager, Clinical Operations Lead Resume
- Experience in Clinical Operations in a medical device/pharmaceutical regulated industry, with previous supervisory experience required
- Effectively negotiate and influence peers, affiliates and Regulatory agencies to ensure that regulatory and business needs are met is required
- Experience with payment validation
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Good ability on coaching/mentoring and developing staff
- Chairs SMT meetings and drives effective study team operations through goal setting and influencing a matrix team
- Experience in staff training and development specifically dealing with providers and staff
5
Skills For RTS Manager, Clinical Operations Resume
- Strong working knowledge and applicable understanding of CFR and ICH guidelines
- Modify action plans as required due to changing circumstances and implement changes in an effective manner
- Experience managing personnel (internal and/or external)
- Establish efficient / effective working relationships with other functional Leaders and coordinators across geographies and projects within a given program
- Relevant clinical research experience in a pharmaceutical company or CRO - relevant clinical research with monitoring background
- Broad experience conducting late phase, post approval, and outcomes research studies
6
Skills For Study Manager, Clinical Operations Resume
- Comprehensive knowledge and understanding of European/FDA regulations and ICH Guidelines for Good Clinical Practices required
- Experience in pediatrics inpatient nursing
- Complete understanding and application of principles, concepts and practices of Good Clinical Practice (GCP) is required
- Experience managing teams
- Coding experience
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
- Experience in a clinical, quality or closely-related setting
7
Skills For Associate / Manager, Clinical Operations Resume
- Forward-thinking and proven leadership responsibilities in a related business environment
- Experience in a clinical, quality or closely-related setting
- Previous experience managing projects and people is necessary to provide leadership and guidance to staff
- Provide mentoring to less experience team members
- Experience in startup through completion of clinical trial conduct in compliance with or to standards consistent with 21 CFR and ICH
- Experience with budget/contract negotiation and execution
- Demonstrates AMN leadership competencies as a collaborative partner with all team members, including external and internal stakeholders
- Demonstrates initiative and ability to make managerial decisions, aligned with AMN standards and policies, ethics and compliance program
8
Skills For Business Change Manager, Clinical Operations Resume
- Monitor Study adherence to protocols, good clinical practices and standard operating procedures; also determines study completion
- Relevant supervisory experience - Line Manager or Project Manager
- Leadership experience in inpatient nursing
- Psychiatric clinical experience
- Pediatric clinical experience
- Demonstrated ability to lead and motivate a group of clinical research personnel
- Prior project team leadership/management is required
- Educational / Industry Experience
9
Skills For Senior Associate Manager, Clinical Operations Resume
- Advanced knowledge and skill in Healthcare Operations: EMR, Practice Management System, Clinic Operations, Health Care Cost management, and related systems
- Directly related experience in medical practice management
- Experience as a Clinical Research Associate required
- Operations management experience
- PICU - One year of which shall have been in pediatric critical care nursing and have evidence of successful completion of AHA approve PALS
- Protocol, Report and Investigator’s Brochure writing experience
10
Skills For Senior Manager Clinical Operations / COM Resume
- Experience in clinical operations methods and processes in industry setting required
- Experience in the preparation and execution of annual budgets
- Manage high priority claims and escalations as well as manage and track assigned department workload re-distributing as necessary
- Demonstrates knowledge of clinician file audit process and monitor file audit resolution
- Demonstrates initiative, recognizing and embracing opportunities for improvement
- Utilize current and innovate future opportunities for standardization of effective operational processes across all TIRS-affiliated facilities
List of Typical Responsibilities For a Manager, Clinical Operations Resume
1
Responsibilities For Senior Manager, Clinical Operations Resume
- Contributes to and executes projects and deliverables that cross many functional boundaries. Primary liaison to the Plans’ FEP healthcare analyst and multiple functional areas concerning the maintenance of benefit cost models and strategies for FEP
- Monitors clinical competency of staff to ensure patient care is delivered appropriately and consistent with OptumCare’s best-practices and industry standard measures
- Substantial monitoring/data management experience or equivalent experience in clinical research
- Comprehensive knowledge and understanding of global regulations and ICH Guidelines for Good Clinical Practices required
- Related oncology clinical trial management experience
- Establish service priorities, work routine and flow patterns and monitor work flow to assure prompt and efficient delivery of services
- Develop, prioritize and meet measurable short and long-term goals for clinical study programs
- Prioritize issues identified by business partners, internal team members and/or partner representatives and monitors progress in the resolution of the issues
2
Responsibilities For Manager Clinical Operations Resume
- Knowledgeable of Good Clinical Practices (FDA and ICH Guidelines), and other applicable regulations
- Overseeing the tactical execution of the study operational strategy by the CRO(s)
- Oversee financial and human resource management including work assignments, forecasting, planning and tracking
- Responsible for talent management of the function, including workforce planning to ensure accurate capacity and efficient onboarding of new personnel
- Mentors, develops, and assesses direct reports including monitoring and managing workload and assignments
- Ensures that staffing patterns meet work requirements and that all employee are competent (annually training, and annual performance evaluations are complete)
- Knowledge of basic financial concepts as related to forecasting and budgeting. Understands project budgets
- Provides input to forecasting and planning activities
3
Responsibilities For Associate Manager, Clinical Operations Resume
- On-site clinical monitoring and/or co-monitoring with CRO CRAs
- A working understanding of cross functional drug development
- Responsible for working with key individuals in clinical operations and in other functions for the planning, implementation and execution of clinical trials
- Manage projects to coordinate biological safety testing for Baxter’s product portfolio
- Perform Study initiation visits directly or by managing others
- Develop and maintain tracking systems as needed for study management, e.g., screening, enrollment, study completion, (serious) adverse events, budgets and forecasts, milestones
4
Responsibilities For Senior Manager, Clinical Operations Lead Resume
- Ensure the safety monitoring plan/ safety tables has been agreed to by Medical Monitor and Vigilance/Surveillance functions as appropriate
- Partner with Legal to ensure adherence to company policies and procedures and legal requirements, while meeting the goals of the department
- Create and develop highly-functioning teams
- Accountable for all study timelines, resourcing, and budget management (20%)
- Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices
5
Responsibilities For RTS Manager, Clinical Operations Resume
- Ensures all workflows are up to date and staff are consistently following processes
- Participate in the preparation and writing of Investigator’s Brochures, SOPs, and clinical sections of INDs and IND Annual Reports, DSURs, NDAs
- Participate in preparing SAE reports for IND submission and, if appropriate, for IRB submission
- Deep understanding of clinical development within Phase IV
- Active nursing practice in an area of similar clinical expertise
- Kentucky or Compact State Nursing License or Licensed Clinical Social Worker
6
Responsibilities For Study Manager, Clinical Operations Resume
- Identify reporting needs and collaborate on report development
- Maintain that training files are up to date and complete in accordance with SOPs and ICH/GCP
- Supports management in assuring integrity and adherence to company principles of Customer Service
- Make recommendations for timing, logistics, and feasibility for proposed studies
- Ensure that appropriate cost monitoring systems are in place and that accurate project accountability is maintained
- Interface with data management to establish a clinical data management plan for each project
- Perform study closeout procedures, directly or through other resources, including accurate completion of critical documents, disposition of study product and preparation of study sites for regulatory authority audits
- Monitors clinical competency of staff to ensure patient care is delivered appropriately and consistent with OptumCare’s best - practices and industry standard measures
7
Responsibilities For Associate / Manager, Clinical Operations Resume
- Partnering with the Study Lead Scientist and other functions to develop scientifically robust, operationally feasible and clear protocol concepts and protocols
- Utilizing operational expertise and scientific assessment to evaluate study feasibility
- Leading/chairing the cross-functional Study Management Team and ensuring that all the supporting functions across Biogen involved in the planning and implementation of the study are effectively contributing to study delivery; ensuring the proactive identification and resolution of issues across those functions
- Building a rich knowledge of specific Area(s) of Expertise specific to the conduct of early phase clinical studies. They are a mentor / SME for the Early Clinical Operations group and leveraged by other groups within ECD and across Development Sciences for their early phase operational expertise
- Provide CLO study activity timeline and budget inputs to overall Study
8
Responsibilities For Business Change Manager, Clinical Operations Resume
- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems
- Manage all contractual negotiations and arrangements with external organizations
- Interface with external organizations and academic partners
- Drive execution of synergies in Knowledge Management between Oral Care and Personal Care categories
- Execute mandatory legal and compliance clearances for planned projects
- Maintain detailed documentation of all contracting activities, including approvals, justification for decisions, and other related information. Compile reports and analyses of contracting activity
9
Responsibilities For Senior Associate Manager, Clinical Operations Resume
- Guide the team in selecting the appropriate contracting format through the approval process for all agreements
- Serve as a resource for interpretation of applicable compliance policies and procedures
- Manage costs of potential contracts and clinical trials in regards to material, equipment services, performance requirements, and delivery schedules to ensure accuracy and completeness
- Liaison with University partners to identify faculty and research capabilities for key Colgate projects
- Exercise independent judgment to plan and prioritize diverse workload, handle frequent deadlines, take initiative, self-motivate and function autonomously
10
Responsibilities For Senior Manager Clinical Operations / COM Resume
- Work independently and possess excellent data gathering skills and the ability to creatively solve problems and formulate/implement process improvements
- Proficiency in MS Office, financial software applications and reporting packages
- Collects, analyzes, synthesizes and/or maintains complex data utilizing databases, survey instruments, information resources, or other research methodology. Advises and supports Plans on data analysis and reporting to support benefit cost, Care Coordination, and care management initiatives
- Advises and supports Plans and internal business partners on data analysis and reporting in support of benefit cost and/or care management initiatives. Continues to identify and assess opportunities for process/systems improvement
- Assist Director, Clinical Support & Safety Officer with establishing, implementing, and ensuring completion of all safety related activities for CCP
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