Clinical Team Manager

Ergomed•Raleigh, NC

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 monitors resource allocation and trial activities to ensure CMP requirements are progressing. The role proactively identifies, resolves or mitigates, and escalates risks and issues to the PM, PD, CTM Line Manager, and Clinical Operations leadership. The CTM manages the project’s allocated clinical team and supports the Project Manager in study execution and oversight, including monitoring key performance indicators, site and staff deliverables, budgets, invoicing, and cross-functional processes. The role contributes to clinical operations risk management, investigator and site selection, site activation and initiation, monitoring, trial master file quality and reconciliation, study supply management, data and query review, deviation and non-compliance oversight, and trial close-out. The CTM works with CRAs, the Sponsor, investigators, vendors, and internal departments; supports audits and inspections; contributes to corrective and preventive actions, training and mentoring, SOP development, bid defense meetings, and process improvement initiatives. Monitoring activities may also be performed as required by project needs. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. It partners with small to midsize biotechnology companies on complex early-phase development trials. The company describes its international team and culture as collaborative, supportive, flexible, and committed to work-life balance, with a focus on quality, integrity, drive, agility, belonging, and collaborative partnerships.

Requirements

Degree or RN degree in a life science or other related field, or equivalent education and experience.
At least 6 years of clinical research experience across multiple studies and countries.
Experience managing the clinical part of studies in more than one region, or 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 success in clinical trials.
Expertise and skills across diverse therapeutic areas.

Responsibilities

Manage the project’s allocated clinical team, including CRAs.
Develop, review, and revise project documents, such as the Clinical Monitoring Plan, site management plans when applicable, site visit report templates, CRF completion guidelines, study operating manuals, and study-specific forms; perform user acceptance testing where applicable.
Support the Project Manager in executing and overseeing study KPIs and staff and site deliverables within required time and budget, including site activation and recruitment targets, query resolution, source data verification, and timely issue resolution.
Support project processes in cooperation with other departments, confirm completed Clinical Operations units or tasks for client invoicing, and approve project-related time spent by assigned staff.
Contribute to Clinical Operations risk management, including identifying, evaluating, controlling, communicating, reviewing, and reporting risks, and contributing to Critical to Quality Factors and Quality Tolerance Limits discussions and proposals.
Recommend investigators and sites to the Project Manager and Sponsor when contracted to Ergomed; review and approve pre-study visit reports.
Oversee site initiations, including initial supply management, and verify required documents are in order for site activation.
Coordinate and manage CRA site assignments and site visit schedules.
Organize and facilitate internal project team meetings, including regular CRA calls, and provide study status and protocol deviation or non-compliance updates at external meetings.
Support the Project Manager in establishing and maintaining trial master files (TMFs) in accordance with Ergomed and Sponsor SOPs and the study filing plan; perform ongoing and final quality control of assigned TMF sections and ensure clinical TMF country and site file reconciliation before trial transfer to the Sponsor.
Review CRA site visit reports and ensure they are finalized on time and are of appropriate quality.
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 of CRAs and site staff as needed.
Oversee protocol deviation documentation, tracking, and escalation; review cumulative non-compliance listings, assess trends, and communicate recommendations for additional corrective or preventive actions to responsible parties.
Act as site contact when a CRA is unavailable and report site issues that cannot be resolved at CRA or CTM level to the Project Manager or designee with an action plan or proposals for discussion.
Oversee and verify execution of tasks assigned to clinical staff for the study, including approval of CRA travel arrangements.
Manage successful trial close-out and identify critical activities needed for timely and efficient close-out.
Communicate and collaborate directly with Sponsor representatives as required; inform and escalate problems involving investigators, Sponsors, or partners, and immediately escalate quality, safety, or legal issues to appropriate leaders.
Participate in study newsletter development when applicable.
Collaborate cross-functionally to develop patient recruitment and retention plans.
Coordinate preparation for site-specific audits and inspections, attend internal project audits when required, analyze audit findings, support root-cause investigations, and propose and oversee corrective and preventive action plans.
Initiate corrective and preventive 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 maintain consistency with Good Clinical Practices and applicable regulatory standards and requirements.
Participate in preparing for, attending, and presenting at bid defense meetings.
Participate in company process improvement initiatives.
Perform monitoring activities as required by project needs.