Clinical Operations Manager Resume Sample
Estella Kreiger
6777 Johns Plains,
Chicago,
IL
+1 (555) 228 6853
Work Experience
Clinical Operations Manager
09/2017
-
PRESENT
Philadelphia, PA
- Actively participate in the MAP process, developing annual performance goals, in collaboration with LTSS Director’s for direct reports and monitoring progress on a regular basis
- Serves as team’s primary support for technologies, including but not limited to PC/laptop, air care, cell phone, etc.; and,
- Related experience in (conducting) clinical studies (healthcare setting, CRO, medical device and/or pharmaceutical company and/or industry)
- Represents clinical operations area for internal and external implementations as the clinical subject matter expert
- Performs initial and annual delegated utilization management NCQA reviews, identifying gaps and presenting to appropriate committees
- Manages medical policy review assuring compliance with Conn General Statutes
- Oversees and manages medical policy review with external physician reviewers
- Manages and monitors departmental corrective action plans to drive and support performance metrics
- Presents at various internal and external physician committees
Clinical Operations Manager, Nicu
03/2011
-
08/2017
Houston, TX
- Leads implementation projects to improve efficiencies within the department
- Partners with the configuration team to assure the appropriate codes are used for authorization/claims matching
- Updates coding of prior authorization list on a semi-annual basis
- Responsible for management of clinical program operations in accordance with AAAHC standards, Federal, State and DOE requirements
- Provide physician-level medical services and medically oversee work and provide consultative support to other health professionals, to include direct supervision of designated clinical staff
- Provide medical expertise in all areas of occupational medicine, including emergency medical care to Laboratory employees with a wide range of potential medical and surgical problems. Take steps to stabilize critically ill or injured patients and make appropriate decisions regarding their transfer off-site as well as serve as Medical Review Officer (MRO)
- Provide diagnosis and treatment of occupational illnesses and injuries following OSHA recording and California worker’s compensation requirements
- Provide medical surveillance and certification exams that are consistent with regulatory standards, federal law, and LLNL and HSD policies
Manager, Clinical Operations Manager
01/2006
-
10/2010
Boston, MA
- Perform pre-placement medical evaluations and fitness for duty evaluations involving assessments of work ability, need for workplace accommodations and restrictions, and determination of the need for medical follow up
- Champion and lead critical health-related activities and evaluations of the workplace health issues, in collaboration with other ES&H professionals, including: participation in ES&H work teams, field work site visits, ES&H program development, medical surveillance program implementation, educational presentations and other liaison activities
- Develop, evaluate, interpret, recommend, and implement policies and procedures for all components of occupational medicine, including medical surveillance and certification, worker compensation, health promotion, emergency response, and medical epidemiology
- Good experience with clinical project management and coordination
- Good knowledge of local regulatory environment and submission and approval processes
- Facilitate Sr. Leadership staff meetings. Prepare agendas and minutes
- Provide guidance and oversight to Administrative Assistant programs. Coordinate training and best practices for administrative support team
- Plan and lead team building events to support All For One AbbVie team dynamic
- Support functional communications, including publishing monthly newsletter, and maintenance of Pharmaceutical Development SharePoint site
Education
Lock Haven University of Pennsylvania
2000 - 2005
Bachelor's Degree in Nursing
Professional Skills
- Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal
- People management skills would be essential, experience leading a team of CRA's or team within Study Start Up
- Some supervisory experience and significant experience in a clinical research setting
- Strong Decision Maker: Decisions are based on analysis, experience, and judgment; most solutions/suggestions turn out to be correct; sought out for advice
- Prior site management experience is required
- Proven ability to adeptly manage multiple priorities; a person who "gets the right stuff done"
- Exceptional problem solving, decision making, and analytical skills
How to write Clinical Operations Manager Resume
Clinical Operations Manager role is responsible for interpersonal, training, clinical, organizational, leadership, medical, research, planning, graduate, computer.
To write great resume for clinical operations manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Operations Manager Resume
The section contact information is important in your clinical operations manager 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 Clinical Operations Manager Resume
The section work experience is an essential part of your clinical operations manager 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 clinical operations manager responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical operations manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Operations Manager resume experience can include:
- Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members and direct reports
- Interpersonal skills to work effectively with students, patients, their families, and other members of
- Strong computer skills and knowledge of Microsoft Outlook, Word, and Excel required.Experience/proficiency using an electronic medical record required
- Open-minded, excellent communication and leadership skills
- Strong communication skills (both written and verbal) and comfortable with managing difficult conversations
- Strong interpersonal skills with the ability to interact with all levels of employees and clients
Education on a Clinical Operations Manager Resume
Make sure to make education a priority on your clinical operations manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical operations manager 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 Clinical Operations Manager Resume
When listing skills on your clinical operations manager 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 clinical operations manager skills:
- Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills
- Excellent interpersonal and organizational skills, sufficient to multi-task in a fast-paced environment with changing priorities
- Analytical skills including call center KPIs, staffing and capacity planning experience
- Strong organizational, decision making & critical thinking skills
- Excellent written & verbal communication skills, background in motivational interviewing desired
- Strong strategic, and proactive thinking skills; able to make and support decisions
List of Typical Experience For a Clinical Operations Manager Resume
1
Experience For Clinical Operations Manager, Nicu Resume
- Solve problems and deal effectively with a variety of variables in situations of limited standardization
- Effectively communicate management strategies, policies and procedures in conjunction with leadership teams
- Five years clinical research experience
- Develop and maintain effective relationships with management team to manage assigned staff in a matrix environment
- Understanding of a local, community based, care management model, delivered both in person, and telephonically
- Directs and / or delegates coordination between patient / client intake, scheduling, care plan development, and resource utilization
2
Experience For Associate Clinical Operations Manager Resume
- Deliberately facilitates team building and inter-disciplinary collaboration
- Maintain a comprehensive working knowledge of managed care, benefits and services for target population to maximize member and program outcomes
- Proficiency in Microsoft Office and working multiple platforms
- Ensure appropriate training for clinical studies teams and clinical studies sites in compliance with ResMed’s applicable processes and ICH GCP
- Monitor staff productively by routinely reviewing staff's daily stats and conduction QA of completed work
- Assist Senior Operations Manager with Finance related tasks and activities
- Expertise in core clinical, and regulatory
- Support implementation of key standard processes that lead to positive and measurable impact for clinical programs managed by the clinical research team (e.g. quality, efficiency, consistency)
3
Experience For Manager, Clinical Operations Manager Resume
- Support and manage coordination of activities across clinical teams for the completion and continued execution of process improvement and compliance related initiatives as requested
- Track and report on high performance standards (KPIs) and metrics for quality oversight of clinical operations related activities
- Responsible for building in country relationships with our clinical trial investigators & site staff. Liaise with site in regional language to ensure study teams deliverables are met to time, cost and quality targets
- Building network of experts in new disease areas as required
- Provides complex scientific amd technical leadership in determining research priorities amd the plan, design amd execution of research projects ensuring that programs of investigation meet specified objectives
- Support the conduct of Regional Medical Investigator’s meetings from an operational perspective as needed
- Establish mechanisms to track and report 3M’s global clinical research activities and impact
- Assists with determining goals, objectives, outcome measurements and metrics, recharge feasibility, and collaboration opportunities as it relates to clinical research with other internal and external organizations. Implements policies, procedures, and training for partners
- Seven (7) + years of related clinical trial monitoring and management experience. Highly competent knowledge of transplant patient care and apheresis collection required within at least one global region is highly desirable
4
Experience For State Clinical Operations Manager Resume
- Deal with time demands, incomplete information or unexpected events
- Attends management meetings, and participates in other hospital committees as required. Complies with BMC managerial expectations, such as regular attendance at managers’ meetings, safety training, annual diversity training, etc
- Participates in practices’ and hospital-wide quality assurance activities. Leads practices, efforts in continuous quality improvement by involvement in teams as appropriate and by supporting changes recommended through the continuous improvement process. Participates in establishing and implementing quality assurance standards
- Identify and escalate GCP issues identified through regular interactions with direct reports and conduct of Accompanied Field Visits
- Refer consumer to appropriate social services provider based on intake information, consumer socioeconomic status, and consumer’s schedule Recognize local social service providers that connect with target population through community relations
- Manages/oversees the conduct and execution of assigned clinical trails and associated activities in accordance with Good Clinical Practices (GCP) and relevant standards
- Maintains professional and technical knowledge by staying current with pharmaceutical industry research and developments as appropriate
- Assists with the review and determination of appropriate site and vendor selection and ensures all vendors meet predetermined program milestones
- Interacts with internal and external groups (CRO’s, vendors, clinical sites, etc.) to facilitate clinical trials and achieve designated timelines
5
Experience For Senior Associate Clinical Operations Manager Baltic States Resume
- Oversees and participates in the review of clinical trial data and clinical trial files. Provides clinical trial review of annual reports and IB updates
- Participates in the periodic review and revision of departmental policies and SOP’s to assure compliance with GCP and Corporate policies
- Keeps management informed of escalating issues requiring intervention into a study or project team. Acts on constructive feedback from peers, supervisors and colleagues to improve performance
- Excellent written and oral communication skills. Ability to communicate in medical and scientific terms with vendors, consultants, and peers
- Thorough working knowledge of the clinical trial lifecycle from protocol development and feasibility through study closeout and reporting
- Read analyze and interpret professional journals, technical procedures and or government regulations. Ability to write reports, business correspondence and procedures
- Provides clinical operational oversight for teams of field based assessor staff and supervisors administering Independent Assessments of beneficiaries
6
Experience For Clinical Operations Manager, Study Start Resume
- Collaborates across the organization including with Medical, Site Directors, senior leaders and other stakeholders
- Communicates in a culturally sensitive manner to individuals whose support needs are being assessed, including beneficiaries within the mental health, developmental disability, or adult aging populations
- Monitors, manages and controls operational and performance metrics in conjunction with established program value target
- Directs the recruitment, hiring and development of sufficient clinical and non-clinical staff to ensure the delivery of safe and consistent quality care to all patients
- Assures that clinical caregivers have demonstrated the ability to perform accurate and complete assessments, communicate with physicians, plan for service delivery, plan for discharge and make excellent professional decisions
- Procures or delegates procurement of all equipment and supplies needed for HME and other departments insuring best pricing for all equipment and supplies
7
Experience For Area Clinical Operations Manager Resume
- Creates and maintains supply and equipment inventory levels
- Reviews all supply and equipment bills from vendors to insure bills are legitimate and appear on the master order
- Resolves any and all vendor issues or disputes
- Supervises clinical and operational processes by managing the responsible staff and assuring the flow of information and documentation from inquiry through discharge of all patient / clients, including providing support and documentation needed to facilitate reimbursement
- Ensures appropriate care coordination among various departments of branch
- Provides back up support and handles other functional role responsibilities, as required, to assure that operational needs are met
- Partner with clinical team to ensure quality. Designed to oversee patient intake and inquiries and assess patient needs
8
Experience For Clinical Operations Manager, Orange County Resume
- Responsible for the supervision of assigned direct reports within Clinical Operations, CoSource and/or Global Site Services Staff
- Responsible for detailed performance review and management of assigned direct reports including: Annual Performance Management and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and "Shoves & Tugs"
- Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business
- Escalate potential individual training needs and assist in the conduct of training and develpment efforts, regionally
- Responsible for appropriate management and resolution of performance issues
- Measure performance indicators for assigned staff
- Conduct, report and follow-up on Quality Control Visits (CQC)
9
Experience For Clinical Operations Manager Periop Services Resume
- Develops, recommends, implements and interprets new or revised policies, standards and procedures; monitors and enforces compliance
- Tracks the flow of medical records and patient information
- Leads and directly manages a team of Care Management Supervisors, Social Workers, Community Health Educators, and Behavioral Health Specialists, upholding all program objectives to optimize business, clinical and operational performance and outcomes
- Prepares, analyzes and applies pertinent data, metrics and reports to monitor and enhance quality, productivity, and assure adherence to policy and procedures
- Coaches and guides clinical supervisors and other staff, in order to build individual and team competencies and performance
- Knowledgeably manages a virtual, work at home workforce
10
Experience For Regional Clinical Operations Manager Resume
- Participates in the clinical leadership team to promote continuous quality improvement and actively contributes to care management best practice standards and strategies
- Adheres to care management and quality management processes in compliance with regulatory and accreditation guidelines and company policies and procedures
- Travel within a designated geographic area
- Build relationships and work collaboratively within an inter-disciplinary team model
- Accountable for resource management for assigned team
- Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie research goals, priorities, and specific study timelines
- Responsible for the acquisition and retention, performance management, and growth and development of talent
List of Typical Skills For a Clinical Operations Manager Resume
1
Skills For Clinical Operations Manager, Nicu Resume
- Strong negotiation skills, excellent at influencing, training/mentoring skills
- Strong leadership skills / Requires expertise of core clinical systems, tools and metrics
- Demonstrated leadership and customer relations skills
- Good project planning, organizational skill, team work and working attitude
- Demonstrated experience managing a team of employees in a Sterile Processing Department
- Consult with sales and marketing to effectively communicate the results of and improvements made due to the quality management program
- Healthcare administration experience required, including at least two years of supervisory experience
- Good Judge of Talent: Hires the best and strongest people available; articulates strengths and limitations of talent and assembles talented staff
- Strong clinical coding and reimbursement experience is required
2
Skills For Associate Clinical Operations Manager Resume
- Knowledge of clinical informatics, computer skills, and adult learning theory
- To effectively lead and develop teams to support the timely, compliant, and scientific clinical research programs to commercialise products and therapies
- Advanced English skills required
- Working knowledge and high experience with electronic data capture systems and clinical trials management systems
- Competence and experience with Electronic Management of Nursing Operations functions (staffing, scheduling, payroll, quality assurance tracking)
- Proficiency in the use of personal computers,including experience with word processing, spread sheets, email and web-browser applications
- Direct experience working in a medical setting
3
Skills For Manager, Clinical Operations Manager Resume
- Three years’ experience in managing clinical studies or projects
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
- “Pay for Performance” with strong merit-based pay increases
- Progress Management experience
- Responsible for the day to day management of the program to drive maximum effectiveness and efficiency and the incorporation of ongoing quality improvements
- Interface with matrix partners in order to foster and improve integration and the overall health care experience of the individual
4
Skills For State Clinical Operations Manager Resume
- Line management experience
- Line management experience across different locations
- Proficiency in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications
- Experience in a call center/contact center management
- Strong ability to work independently in a geographic region with minimal supervision
- Clinical research experience
5
Skills For Senior Associate Clinical Operations Manager Baltic States Resume
- Experience in healthcare management, staff selection and development, complex project management
- Experience in behavioral health, direct clinical practice
- Experience in Clinical Research
- Progressly responsible and directly related work experience
- UB04 claims experience
6
Skills For Clinical Operations Manager, Study Start Resume
- 5 – 7 years of clinical research experience
- In Billing and/or Collections Hospital Management experience
- Experience in implementing Lean principles and Continuous Process Improvement Methodology
- Extensive experience with the methods of population-based health analysis and prevention
- Five years clinical operations program management experience
- One year electronic health records (EHR) experience
- Clinical Research experience is required
- UB04 claims experience
7
Skills For Area Clinical Operations Manager Resume
- Position requires extensive experience in clinical research operations
- A few years clinical research experience in a pharmaceutical company/CRO on a CRA position
- Experience in Women's Health required
- Collaborate with division clinical managers to develop clinical studies to support division’s priorities and businesses
- To be the subject matter expert with a focus on operational excellence and efficiency across the planning and development of clinical evidence
- Provides clinical expertise and business direction to operationalize protocols and drive the effective execution of care management services
8
Skills For Clinical Operations Manager, Orange County Resume
- Clinical experience required
- Lead CRA, Sr. SSUA, Project Lead, Project Manager with strong leadership
- Experience of Care - relationship-centered care grounded in empathy, dignity, respect and collaboration
- Analyzing Lights-On dashboard reporting and trending information
- Forecasting and tracking of operational budget in conjunction with CRD
9
Skills For Clinical Operations Manager Periop Services Resume
- Understanding of clinical research systems, building reports and analyse data
- Providing direction and leadership for our outsourcing partners in day to day operations
- Working on initiatives lead by functional heads of CRA monitoring to support global consistency, focus and development across their remit
- Understanding of behavior modification, motivational interviewing and adherence related interventions
- Managing a team of Clinical Trial Assistant, CRAs Entry Level(inhouse CRAs) and Junior CRAs
- Working as a key project lead on process improvement, efficiencies and technological development to enable to group to deliver on its year on year targets
10
Skills For Regional Clinical Operations Manager Resume
- Working across your peer group to develop key people processes, success to be implemented into the region
- Analyzing quality and performance reports for trends and making recommendations for process improvements where necessary
- Ensuring compliance to program policies & procedures
- Collaborating with Compliance team on program audits, address audits findings and implement corrective action
- Leading projects with diverse stakeholders (physician champions, informatics, app support teams, IT, etc.)
- Participating in governance of Root Cause Analysis
- Ensuring Disaster Recovery tests are completely annually and reported in a standardized fashion
- Billing Inventory includes: Acute Care, both In-Patient and Out-Patient Behavioral Health, both Adult and Pediatric Long Term Care
- Leading, Coaching, and mentoring your team
List of Typical Responsibilities For a Clinical Operations Manager Resume
1
Responsibilities For Clinical Operations Manager, Nicu Resume
- To work with Medical Affairs Managers and Senior Leadership to develop clinical evidence strategies and plans to support the delivery of clinical evidence to support business needs within therapy and product families
- Identify potential improvements in processes and systems, and lead collaborative work packages to ensure operational excellence and continuous improvements to the Medical Affairs processes to keep pace with business needs and changes to Regulations
- Knowledge of Good Laboratory Practice (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) is an asset
- Evaluate, develop and coordinate projects using skills such using collaboration, motivation and knowledge of clinical analytics to help drive decision making
- Effectively hire, develop and manage the clinical staff to enhance the operational and business success and to assure adequate services in the donor processing
- Prior business management experience
- Advanced oral, written and presentation skills
- Support the highly reliable execution of evidence practices in improving patient experience
- Collaborate with clinical teams, Consumer Experience and Human Resources a differentiated Intermountain extraordinary care experience
2
Responsibilities For Associate Clinical Operations Manager Resume
- Competencies in leading highly effective teams, managing, developing and motivating direct reports
- Ensures that new skill training and ongoing competency verification is completed
- Passionate about changing the healthcare experience for our members and improving their health
- Advance, with others, the use of predictive analytics and deep learning computing to improve the health, experience and quality of care of those we serve
- Direct experience managing Clinical Research Associates is
- Proven expertise of all code sets (CPT, ICD-9, HCPCS Level II), evaluation and management principles, and documentation guidelines
- Manage multiple projects and prioritize work independently
- Demonstrated competency in quality improvement and data interpretation
- Clinical experience, directly associated with patient care that could include nursing, case management, health coach
3
Responsibilities For Manager, Clinical Operations Manager Resume
- Experience in clinical research
- Healthcare supervisory/management related experience
- Experience in behavioral program implementation, maintenance and restructure
- Experience in management of larger healthcare programs (50-150)
- Active RN License and in good standings required
4
Responsibilities For State Clinical Operations Manager Resume
- Managing the local clinical operations team by empowering and coaching them to deliver their key objectives
- Generating and analyzing technical reports
- Leading the overall delivery, through your operational team, to drive execution of service, client satisfaction, quality and efficiencies
- Responsible for assisting in the trending and tracking of identified variances in care, root cause analysis and seeking and supporting resolution as assigned
- Create process maps and related documentation including documents supporting training development
- Individual is proficient with on-site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)
- This role is also responsible for ensuring Cerner EMR system is optimally tuned and vendors are meeting routine obligations
- Oversees day to day operations; responsible for problem solving, and providing quality services
5
Responsibilities For Senior Associate Clinical Operations Manager Baltic States Resume
- Ensures quality programs by reviewing outcomes and following up as needed to address outcome issues
- Nurture a robust culture of caring through support of caregivers (well-being, joy, resilience) and attention to what matters most to our patients
- Driven: Pursues everything with energy and seldom gives up before finishing, especially in the face of resistance or setbacks
- Develops local language materials required for submission to HA and IEC, including local language Informed Consents and translations
- Develop process measurement techniques including Key Performance Indicators
- To mentor and lead a team of around 20 Study Start Up staff in Korea, working with and through others
6
Responsibilities For Clinical Operations Manager, Study Start Resume
- Deliver training to members of the team as well as global study teams to ensure quality and alignment of processes
- Input to Director or VP on budgeting discussions for your country to drive productivity and quality within the region
- Travel (approximately 40%-50% depending on country structure and direct report levels) domestic and/or international
- Comprehensive understanding of clinical and regulatory standards, compliance requirements, quality assurance and quality control within a clinic environment
- Work in a high stress, constantly changing environment
- Contributes to strategic planning, standardization, best practices, and attainment of organizational goals
- Responsible for development, implementation, and management of annual capital/operating and personnel (FTE) budget for region
- Medication and/or chronic condition behavior coaching
- Whenever possible describe the savings to patients and the organization resulting from improvement in Quality
7
Responsibilities For Area Clinical Operations Manager Resume
- Partner and support the ongoing efforts in Employee Safety
- Respond to challenges with patience, empathy, and tenacity while maintaining a flexible attitude
- Proactively identify issues impacting patient care and/or office operations and involve up-line operations management and/or clinical operations
- Keep abreast of pertinent information regarding policy, regulation, clinical practice, procedures and operations
- To identify, implement, and monitor metrics in order to make improvements to ensure operational efficiency within the team
- Work collaboratively across the organisation to ensure appropriate clinical studies support, training, and coordination of Medical Affairs related activities, including early phase research, market research, regulatory, and marketing communications
8
Responsibilities For Clinical Operations Manager, Orange County Resume
- To manage major projects within the Medical Affairs department as required, including project management of cross-functional and multi-region teams
- Recruit and retain talent with a strong blend of clinical and research capability, cultural fit and alliance to ResMed’s values. Provide growth opportunities for development aligned to the 70:20:10 model. Coach and provide regular feedback to ensure team members grow, develop and be the best that they can be
- Engender ResMed’s Core Competencies, and exemplify ResMed’s values and leadership philosophy
- Serve as the technical liaison for Tenet business stakeholders
- Monitor timeliness and completeness of tasks
9
Responsibilities For Clinical Operations Manager Periop Services Resume
- Foster positive outcomes specific to Dignity Health Employee Engagement
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA)
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with Senior Clinical Operations Manager (SCOM)
- Executes and oversees clinical trial country submissions and approvals for assigned protocols
- Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country
- Accountable for all activities of site related study execution of assigned studies / Monitors involving startup,execution, and closeout
- Contributes to the development of local SOPs. Oversees CTCs as applicable
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable
10
Responsibilities For Regional Clinical Operations Manager Resume
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems
- Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up
- Issues in budget / CTRA negotiations
- Quality and compliance issues
- Issues related to functional area deliverables that could jeopardize protocol
- Ensure audit and inspection readiness of assigned sites. Advise on preaudit activities for GCP requirements
- Prepare and follow up site and system audits, CAPA preparation and implementation
- If assigned; Independently serve as key point of contact in country/district for one or more studies with higher level complexity. Update Impact/Tesla with country level information: Country level planning timelines, LSR
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