Associate Clinical Trial Manager

Opportunity Details

On Assignment Associate Clinical Trial Manager

Malvern, PA

The primary responsibility of the Associate Clinical Trial Manager (Associate CTM) is to manage clinical trial activities under the direction of the Clinical Trial Manager/Clinical Trial Lead (CTM/CTL, respectively). This position coordinates and collaborates with others in cross-functional teams; and oversees the deliverables and accountability of consultants, temporary staff, vendors and contract research organizations (as applicable). This position will support the CTM/CTL for the overall successful planning, implementation, monitoring and closure of clinical studies in accordance with Good Clinical Practices, other relevant regulations, and SOPs.

The Associate CTM will:

• attend applicable internal/external meetings and prepare minutes, as needed.
• collaborate with the study team to achieve corporate and project team milestones on time and on budget including risk mitigation as needed.
• provide oversight to ensure overall study and monitoring compliance ( i.e. start-up, maintenance and close - out phases).
• contribute to the development of full suite of planning tools for each clinical trial, including Study Oversight Plan, Clinical Monitoring Plan, enrollment plan, communication plan, contingency plan, start up and closureplan .
• track and report study metrics (site and patient status, CRF completion, query status, study supply management) againstthe study plan.
• contribute to the development and implementation s of applicable SOPs, study-specific monitoring and site training tools, and deliver/oversee training.
• review and approve site visit reports to identify site and/or study trends and gaps; assist in ongoing study data reviews and data cleaning activities.
• track action items through resolution from site visit reports.
• provide oversight for CRO personnel, including essential document review for quality control (QC); support Trial Master File (TMF) implementation and maintenance.
• develop and foster positive working relationships with site personnel, colleagues, and development and service partners.
• act as primary contact for CRAs and any additional roles as required ensuring escalation of issues and ongoing communication with the CTM/CTL.

The Associate CTM will have:

• a BS degree in biology, allied health, nursing or related life science preferred.
• 6-years of clinical research related or pharmaceutical industry experience.
• 4-years of experience with clinical trials as a CRA or related discipline.
• 5-years of experience leading teams.
• system experience preferred (e.g., CTMS, EDC, eTMF)
• strong working knowledge of GCP/ICH regulations.
• a working knowledge of relevant SOPs.
• proficient with MS Word, Excel, in-depth knowledge of other presentation programs, a plus.
• ability/flexibility to travel (up to 25%); as needed.