Clinical Data Project Manager job in Cambridge, USA

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: CRA Manager, Program Manager / Director, VP/Head of Clinical Operations

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Clinical Data Project Manager with a pharmaceutical company located in Cambridge, MA.

Job Responsibilities:

Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and sponsor for all data related deliverables, especially in support of key decision points and regulatory submissions.
Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
Oversees the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc.
Participates and represents function in formal inspections and audits as requested.

Skills and Requirements:

BS/BA required preferably in a health-related, life science area and with a minimum of 10 years data management and/or drug development experience.
Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
Proven track record of strong project management skills
Experience with all phases of development and at least 2 therapeutic areas

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-BC1