Clinical Study Manager Job Description
Clinical Study Manager Duties & Responsibilities
To write an effective clinical study manager job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical study manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Clinical Study Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Study Manager
List any licenses or certifications required by the position: PMP, ACRP, GCP, IVD, CE, GDPR, IVDR
Education for Clinical Study Manager
Typically a job would require a certain level of education.
Employers hiring for the clinical study manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Life Sciences, Health, Education, Nursing, Project Management, Medical, Healthcare, Management, Technical
Skills for Clinical Study Manager
Desired skills for clinical study manager include:
Desired experience for clinical study manager includes:
Clinical Study Manager Examples
Clinical Study Manager Job Description
- Facilitate short and long term planning for assigned programs
- Assess and appropriately delegate tasks within assigned programs to team members
- Provides tactical and strategic clinical operations oversight and direction ensuring collaboration across multiple phase I project/programs to translate our science into reality through high quality clinical trial conduct
- Responsible for the overall operational execution of clinical studies on clinical projects/programs
- Matrix manage assigned cross-functional study team members to ensure compliance and execution of deliverables within approved budget and timelines
- Manage the implementation, on-time execution and conduct of clinical studies
- Monitor the status of site budget and contract negotiations the collection and review of essential documents
- Develop and manage Study Management plan and all associated documents
- Plan, facilitate and lead SET internal meetings act as the CSL lead for vendor meetings
- Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations
- Previous experience in Cardiology an advantage, but not a must
- Good understanding of clinical research and working knowledge of ICH-GCP
- Work experience with global/regional teams
- Strategic & tactical thinking skills
- Client-focused action-oriented approach to work
- Highly confident to deal with client and internal resources at all levels
Clinical Study Manager Job Description
- In collaboration with the Trial Monitoring key stakeholders (CSM Group Head, Regional Operations Manager (ROM), local/global medical, Trial Operations Manager (TOM), and global clinical assists in the development of local study execution plans and timeline commitments for a Country/Cluster
- Supports study feasibility and country patient commitments in collaboration with Country/Cluster Trial Monitoring and Medical
- Leads site selection in collaboration with Country/Cluster Trial Monitoring and Medical
- Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with Country/Cluster Trial Monitoring stakeholders
- Ensures sites are prepared for “Ready to Initiate Site” (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
- Is the escalation point for issues in monitoring visit reports (MVRs) for the assigned studies, post CRA Manager review (may act as primary reviewer in countries where CRA Managers do not exist)
- Provides feedback about the quality of monitoring activities to CRA Managers and local QA as appropriate
- Supports inspection readiness and submission preparation for monitoring related activities and assists with internal audits and HA inspections, as required, and ensures implementation of corrective actions within specified timelines
- Leads product development or marketing study programs in conjunction with and under direction of Clinical Affairs management, working closely with all departments and key stakeholders
- Manages clinical studies that involve sponsor-initiated studies OUS
- Able to work independently and manage assignments from a distance
- Strong understanding of cultural differences
- Proven client-facing relevant experience in healthcare, clinical research, project management or contract research organization
- Prior Project Management experience required, Critical Path Management preferable
- End to End study start-up experience & expertise preferred
- 3+ years experience in clinical research management
Clinical Study Manager Job Description
- Ability and confidence to run study status reviews and other key team meetings
- Communicates program’s study status to management and cross-functional teams
- Coordinates the management any CROs selected by company to perform site management of a clinical study
- Ability to direct personnel to achieve desired results related to clinical study execution without direct personnel management required
- Devises efficient, effective clinical trial execution strategies
- Exceptional planning, communication, and creative problem solving skills, ensuring trial delivery for clinical trials
- Generation or review of study documents relevant for regulatory submission
- Align activities with team members
- Create and report clinical study updates to management on a regular basis
- Accountable for the implementation and embedding of the Clinical Study Support flexible resource model and eTMF support model supported by our FSP
- Minimum 5-6 years of experience in clinical research (GCP education – LIF/LMI or equal) incl
- Bachelor’s Degree or equivalent is required, typically in nursing, medical or scientific field
- 7+ years of pharmaceutical or biotech-related/clinical research related experience is required
- Considered a subject matter expert and Competent in application of standard business procedures (SOPs, ICH-GCP, Global Regulations, Ethics and Compliance)
- Experience in successful study initiation through study completion/primary data analysis and/or in early phases of clinical development (Phase I-3)
- Must have strong knowledge of ICH/GCP guidelines
Clinical Study Manager Job Description
- Accountable for implementing the new eTMF support model
- Accountable for the identification of appropriate capable resources to support the workload and personal development opportunities for eTMF support model and for global Clinical Study Support staff to support R&D strategies within PCPS
- Drive and ensure an effective model is in place to support the implementation of eTMF across Pharma R&D
- Responsible for ensuring staff work to the highest quality that enables study teams to be ‘Inspection ready’ at all times
- May collaborate with CTS team to plan and coordinate IMP and non-IMP supplies
- May report key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality
- Co-monitor as needed
- Communicate study results through annual reports, investigator meetings, and global clinical discussions
- Participates in the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
- Works with local Drug Supply Management, aligned with BPA, to forecast local IMP and comparator needs as appropriate
- 3-5 years of relevant clinical study management experience
- Current in-depth knowledge of clinical study budget and contract development
- Program Management related to clinical studies
- Medical device, pharmaceutical industry, or other regulated environment experience is required, with medical device clinical study experience high preferred
- Proficiency in Microsoft Office and Visio is required
- Excellent communication skills with the ability to convey clinical, regulatory and business information clearly and effectively through informal and formal documents, reports, and presentations to management
Clinical Study Manager Job Description
- Establishes processes for the collection and initial review of regulatory packets and site contracts for investigator sites
- Oversees local vendor selection and performance as needed
- Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
- Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for approval of enrolling above site targets
- Oversees local clinical team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations
- Leads/chairs local study team meetings or supports Sr
- Maintains oversight of country level or assigned site level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
- Coordinates the study handover process with the CRAs and their managers to ensure proper documentation and communication, when necessary
- Tracks that all study close–out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders
- Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
- Proven ability to manage conflict and work under tight deadlines
- Be a member of the project team interfacing with R&D, Life Cycle Teams, Clinical Development Teams, Medical Affairs, Regulatory Affairs and Biometrics in the study overall design, validation and planning
- Bachelor’s Degree in nursing, scientific, or equivalent required
- Scientific background in biological sciences
- Working knowledge of various tools used in clinical trials including electronic data capture, electronic clinical outcomes
- Bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred