Manager of Clinical Data Management
Proclinical is currently recruiting for a Manager of Clinical Data management for a biopharmaceutical company located in Waltham, MA. Successful candidate will collaborate with internal and external team members for the planning and execution of clinical trials as it relates to data management.
- Ensure quality and data integrity of clinical databases.
- Work with clinical team to define study data review plan specifications.
- Lead clinical team in the review of clinical study data.
- Prepare and provide data listings and reports as required (e.g. leadership reporting, DMCs, etc.).
- Provide review and guidance to protocol development as it relates to data collection and management.
- Provide leadership to the study team with respect to data management activities throughout the study lifecycle: planning, start-up, conduct, close-out.
- Accountable for the creation and delivery of DM documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.); ensure documentation is appropriately filed within the Trial Management File (TMF).
- In consultation with the Director of Data Management, provide guidance to Vendor Management as it relates to development of contracts with external vendors for data collection, cleaning, and reporting; review of Scopes of Work related to data management responsibilities.
- Partner with internal content experts to manage and coordinate data collection/maintenance with external vendors; ensure deliverables are identified and met according to project milestones and program/project objectives.
- Track and document data management decisions.
- Initiate and chair meetings associated with various clinical programs; document and distribute meeting minutes for chaired meetings.
- Provide support and contribute to the development of clinical trial timelines as it relates to data management activities.
- Assist with the review and approval of study vendor payments as it relates to data management. Complete other duties as assigned by the manager.
Skills and Requirements:
- BS degree in Biology, Computer Science or related scientific field.
- 5+ years' experience in data management or relevant work in the pharmaceutical/biopharma industry. Experience in oncology
- Sponsor side experience in managing and overseeing CRO delegated DM activities preferred.
- Experience in managing external vendors (Labs, Imaging, ECG).
- Able to provide independent DM subject matter expertise to study teams and vendors in defining, managing, & delivering on DM obligations. Experience with CDISC standards.
- SAS programming experience a plus.
- Experience working in 1 or more EDC systems (Rave, InForm, Medrio, etc.) and software applications such as Word, Excel and Solid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Excellent interpersonal skills in addition to verbal and written communication skills. Flexibility to travel up to approximately 5% of time.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Junis Citozi at (+1) 929-388-1650 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.
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