Trial Management Associate (TMA) Oncology

The Trial Management Associate is responsible for assisting the CTM/CDM/CTOM/TL/GL within a Trial Operations Group dedicated to a Therapeutic Area BU or across one or more TSUs/DPUs/GMA/USMA, etc. in a specific geographical site with the global trial initiation.

Will conduct and report trial progress by coordinating and performing assigned operational activities.

May need to take-on CPA-level administrative tasks as required to meet business needs and to support a customer-oriented approach for Trial Operations.

Able to mentor CPAs as appropriate.

Operational Responsibilities to be Conducted in Accordance with established Processes, Policies and Standards which may be delegated/assigned

Study Coordination, Tracking, and Reporting

Maintain corporate or local operational tracking and reporting systems including but not limited to: Impact/Profile setup & updates, Impact/Profile/CTI Reports & Accrual Curve Generation, Relevant study budget/financial management systems (including invoice review and payment approval)

Assist with oversight of study metrics (patient status, protocol deviations, etc.), compliance with systems use (eg, IMPACT updates), & provide ad-hoc status reports in accordance with corporate or local electronic systems, reports and processes

Assist with coordination of IP shipments/accountability as relevant to meet study needs in a cost-effective manner, including use of appropriate operational systems and tools (eg, via IVRS, manual system etc as relevant).

Coordinates study materials/ancillary trial supplies preparation and distribution internally or with vendors and ensuring tracking as required

Study Document Development

Assist in development of CRFs and other study related documents (eg, Monitoring Plan, Data Management Plan, etc.), including provision of operational input into content, and/or review of operational input or documents prepared by other CTT members or ven

Skills:

Knowledge and operational experience working in the clinical trial environment

Familiarity with Windows-based computer applications (eg, MS EXCEL, ACCESS and Powerpoint) and working in clinical trial management systems (eg, IMPACT)

Excellent interpersonal and communication skills (verbal and written) including good English and ability to maintain a high-level of confidentiality

Self motivated, detail-oriented, ability to handle multiple tasks efficiently and effectively, and excellent organizational skills required

Ability to work effectively in a team

Education: Bachelors degree.

A minimum of 1 year of experience in pharmaceutical industry or clinical-related discipline including clinical research experience, familiarity with medical terminology, general understanding of the R&D process and previous exposure to GCPs/ICH is required.

Able to mentor CPAs as appropriate.

In lieu of degree, at least 6 years of relevant experience supporting clinical trials
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Country: USA, State: Massachusetts, City: Cambridge, Company: Experis.