The Clinical Team Manager (CTM) is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The CTM leads and directs cross functional teams (Clinical Operations, Regulatory Affairs) and understands/manages client expectations. The CTM proactively identifies, resolves/mitigates and escalates risks and/or issues. Depending on the business unit the descripted ccountabilities may or may not apply.
Provides Project Oversight and Leadership for Clinical Deliverables: Leads and manages the start-up and clinical teams
Plans and leads execution of the day to day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations and status updates.
Works with the team to set priorities
Takes the initiative to make things happen and leads and supports the relevant staff ( this may include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead (GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to ensure the successful activation of trial sites according to time, quality/scope and budget parameters
Motivates the clinical team
Ensures effective communication plans are place for the clinical team
Ensures effective escalation plans are in place for the clinical team
Works with the Project Manager (PM) to facilitate cross functional team and sponsor communication for proactive, study-wide problem solving regarding study progress and trial issues during the study
Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up and resolution of site issues
Identifies opportunities to improve training, execution and quality control across the team
Liaises with relevant staff to provide data as required for clinical operations performance metrics and project status metrics
Works with the relevant staffto identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks.
Attends Executive Project Status Reviews as required
Project Resourcing Works with the relevant staff (including Director of Project Delivery (DPD) when applicable) to ensure all Clinical team members are adequately assigned to the project
Forecasts as per the contractually agreed FTE, tailoring forecasts to peaks and flows of activities throughout the project duration Actively monitors initial and ongoing clinical resource and identifies/escalates issues to the Project Manager (PM)and/or Clinical Management when applicable
Liaises with Clinical Operations Managers to resolve clinical resource and performance issues
Disseminates and agrees forecasted activities/FTE to all key team members
Oversees transition plans to allow seamless transition of knowledge in case of CTM or clinical team member replacement
Quality – Training & Development Creates and maintains project specific plans, documents and tools for the clinical team.
Plans, oversees and conducts initial and ongoing training for the relevant study staff on clinical project specifics
Analyzes data related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies.
Supports the Clinical Research Associates (CRAs) with site monitoring activities and provides suggestions and solutions to site issues where applicable.
Ensures all PRA project reporting systems are up to date for clinical activities at the project level
Oversees the CSS, GRAL, LRAL and IHCRA to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial.
Oversees the GRAL, LRAL and IHCRA to ensure that all non-safety periodic updates, progress reports and renewals and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial.
Identifies metrics and trends across team members, countries, regions and uses the information to promote improvement in quality and consistency of execution.
Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans, responds completely and accurately to audit reports, provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA and then Sponsor Organizes project specific compliance plans for key processes, tools and systems
Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines
Project Finance Provides Time Entry Guidelines to the relevant study team members in adherence with project scope and budget; monitor burn rates, escalating issues with potential solutions to the Project Manager (PM).
Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked units and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget
Ensures that forecasted units are achieved as planned and within the budgeted FTE
Identifies out-of-scope tasks from clinical team and escalates as required
Ensures no out-scope tasks be conducted without the required evidence of agreement from the client or approval by the relevant PRA staff.
Customer Relations (Internal & External) Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are achieved
Serves as primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functional areas, escalating as required
Participates in client meetings, assisting with presentations as required
Contributes to Business Development activities participating in proposals and bid defenses as needed
Performs any other duties required to ensure the success of the trial and/or PRA
Qualifications Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; alicensed health-care professional (i.e., registered nurse); or equivalent work experience required.
5+ years of clinical research experience required, including at least 2 years experience in clinical trial management
2+ years monitoring experience preferred
Experience in managing all trial components (start-up to database lock) preferred
Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives preferred
Read, write and speak fluent English; fluent in host country language required.