Senior Manager, Data Management

Location

Boston, MA | United States

Job description

Senior Manager, Data Management - Permanent - Onsite

Proclinical Staffing is seeking a Senior Manager, Data Management to join a cutting-edge biotech company. This is a permanent role located in Greater Boston, MA.

Skills & Requirements:

• Minimum 5-7 years of experience in Clinical Data Management with practice in oversight of DM activities as a Lead and DM project management. Profound knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects and experience with Clinical Database Systems and processes
• Very good command of English (written and spoken)
• Experience in usual software (Word, Excel, PowerPoint, MS Project)
• Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, …)

The Senior Manager, Data Management will:

• Serves as the primary point of contact for partners and sub-contractors on data management deliverables and activities.
• Provides data management and technical expertise while working with CRO data managers and key decision-makers for end-to-end DM activities.
• Supervises clinical data management activities. Performs direct negotiations with the CRO for timelines, processes, and quality issues.
• Organizes, conducts, and oversees clinical data management activities.
• Participates in the protocol development, creates and/or validates all the data management plan documents (CRF, Validation plan, …).
• Identifies the requirements for the development and amendments of the clinical database in cooperation with the trial team (Managers Clinical Trial, Medical / Clinical Development experts,…).
• Validates or performs sponsor User Acceptance Testing of a clinical database.
• Provides support for sponsor clinical data medical review.
• Escalates unresolved data or compliance issues to the functional manager(s); works with CRO data managers, partners, vendors, and internal team members for resolution.
• Ensures services and quality meet agreed specifications per the DMP quality standards.
• Ensures the final deliverables are provided to the Global Biometry Science team and provides support for data analysis/ output generation.
• Participates in the development and implementation of new technology or tool.
• Participates and supports the RFP process (for DM activities).
• Participates in the CRO selection for DM activities (review of proposals, bid defense).
• Provides support and reviews the Scope of Work / Contracts and budgets for data management activities. Reviews invoices for data management activities as necessary.
• Provides input on developing, revising, and maintaining core operating procedures and templates.
• Provides support or assists the Quality assurance department in conducting audits involving data management activities.

If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at (+1) 305-929-0913 or [email protected] .

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.

Job tags

Salary