Clinical Team Manager

Ergomed • Raleigh, NC

2d

About The Position

The Clinical Team Manager (CTM) is a Functional Lead for Clinical Operations, responsible for operational management of assigned countries and sites and for coordinating and overseeing allocated CRAs. The CTM develops the study Clinical Monitoring Plan (CMP) and oversees resource allocation and clinical trial monitoring to ensure CMP activities progress. The role proactively identifies, resolves, mitigates, and escalates risks and issues to project and Clinical Operations leadership.

The CTM manages the project’s allocated clinical team and contributes to study delivery across site management, monitoring, risk management, documentation, data quality, supplies, and trial close-out. The role works closely with the Project Manager (PM), Project Director (PD), Sponsor representatives, investigators, CRAs, and cross-functional colleagues. The CTM may also perform monitoring activities as project needs require.

Requirements

• A degree or RN degree in life science or another related field, or equivalent education and experience.
• At least 6 years of clinical research experience across multiple studies and countries.
• Experience managing the clinical component of studies in more than one region, or experience with equivalent study complexity.
• Ability to mentor and train CTMs and CRAs in a positive and effective manner.
• In-depth knowledge of clinical trials and the critical elements for successful trial delivery.
• Expertise and skills across diverse therapeutic areas.

Responsibilities

• Manage the project’s allocated clinical team, including CRAs.
• Develop, review, and revise project documents, including the Clinical Monitoring Plan, site management plans where applicable, study-specific visit report templates, CRF completion guidelines, operating manuals, and study forms; perform user acceptance testing (UAT) where required.
• Support the PM in oversight of study KPIs, staff and site deliverables, timelines, budgets, project processes, client invoicing, and approval of assigned staff time.
• Contribute to Clinical Operations risk management, including identification, evaluation, control, communication, review, and reporting of risks, as well as discussions and proposals concerning Critical to Quality Factors and Quality Tolerance Limits.
• Recommend investigators and sites to the PM and Sponsor when contracted to Ergomed; review and approve pre-study visit reports.
• Oversee site initiations, including initial supply management, and verify required documents for site activation.
• Coordinate CRA site assignments and site visit schedules.
• Organize and facilitate internal project team meetings and provide study-status and protocol-deviation or non-compliance updates at external meetings.
• Support the PM with setup and maintenance of clinical trial master files (TMF); conduct ongoing and final quality control of assigned TMF sections and ensure reconciliation of country and site files before transfer to the Sponsor.
• Review CRA site visit reports and ensure they are finalized on time and meet quality expectations.
• Monitor and manage trial materials and ensure Investigational Product and other study supplies are available at sites.
• Review data listings and query reports for trends and ensure proactive mitigation or retraining is implemented with CRAs and site staff.
• Oversee protocol-deviation documentation, tracking, and escalation; review cumulative non-compliance listings, assess trends, and communicate recommended corrective or preventative actions.
• Act as the site contact when a CRA is unavailable.
• Report unresolved site issues to the PM or designee with an action plan or proposed actions for discussion.
• Oversee and verify execution of tasks assigned to clinical staff, including approval of CRA travel arrangements.
• Manage trial close-out and identify critical activities needed for timely and efficient completion.
• Communicate and collaborate directly with Sponsor representatives as required.
• Inform the PM or PD of problems involving investigators, Sponsors, or partners, and immediately escalate quality, safety, or legal issues to the PM/PD, Line Manager, or Head of Department.
• Participate in developing study newsletters where applicable.
• Collaborate across functions to develop patient recruitment and retention plans.
• Coordinate preparations for site-specific audits and inspections; attend internal project audits when required; analyze findings, support root-cause investigations, and propose and oversee corrective and preventative action plans.
• Initiate corrective and preventative measures, such as updating study guidance documents or conducting retraining.
• Mentor and train new staff and conduct Monitoring Evaluation Visits to assess CRA performance.
• Oversee and support contracting or invoicing processes for local vendors performing clinical activities.
• Develop, review, and revise Ergomed SOPs within the area of expertise to support consistency with Good Clinical Practices and applicable regulatory requirements.
• Participate in preparing for, attending, and presenting at bid defense meetings.
• Participate in company process-improvement initiatives.
• Perform monitoring activities as needed based on project requirements.

Benefits

• The company describes a collaborative, international team and a commitment to work-life balance.
• The role offers the opportunity to contribute to bringing safe and effective pharmaceutical treatments to patients.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior