Position information

Company:
Clinical Solutions Group

Location:
Cambridge, MA

Salary/Wage:
70,000.00 - 88,000.00 USD /year

Status:
Full Time, Employee

Job Category:
Biotech/R&D/Science

Relevant Work Experience:
5+ to 7 Years

Career Level:
Experienced (Non-Manager)

559.11749

Industry:
Biotechnology/Pharmaceuticals

Education Level:
Bachelor's Degree

Occupations:
Clinical Research

Industry:
Biotechnology/Pharmaceuticals

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ABOUT THE COMPANY

Clinical Solutions Group (CSG) specializes in providing contract and permanent staffing services to the pharmaceutical industry. Our employees enjoy outstanding salaries, group health/dental insurance, vision, life insurance, short/long-term disability, 401K, paid time off, performance bonuses, training reimbursement, and relocation. We welcome you to see why CSG is considered to be one of the premiere providers by visiting our web site at www.csg-inc.com.

position description

Senior Clinical Data Project Manager - Pharma

Description

Clinical Data Manager works collaboratively with Clinical Operations, Biometrics, PVG, Regulatory and other staff to meet project deliverables. The successful candidate will also have the ability to gather, organize, and analyze clinical data from multiple data sources. The incumbent will provide oversight to CROs, while performing extensive hands-on Clinical Data Management activities from protocol design through regulatory submission. This position will offer the ability to work in a stable and well-established company while also having a high level of visibility.



KEY RESPONSIBILITIES:



Plan, organize, and coordinate global data management activities on a project basis.

Ensure database consistency across all studies within a project.

Manage CRF design, data collection, data retrieval, global integrated database development, UAT and query management for Phase I-IV clinical trials.

Manage all CRO/vendor management.

Serve as the primary contact for all project teams, domestic and global, to ensure data quality and timely database delivery.

Review Data Management performance against established metrics.

Manage database and supporting documentation archival to meet long-term regulatory requirements.

Ensure that all project related outsourcing agreements are comprehensive and complete.

Define and manage CDM project timelines.

Review and provide feedback on vendor RFIs, RFPs, proposals, and contracts.

Lead innovation and implementation of new technologies resulting in process improvements.

Participate in and may lead cross-functional process initiatives.

May have opportunity to mentor and supervise other data management staff.

Requirements

Bachelor’s degree in related science/technical discipline

Minimum of 3-5 years data management experience in Pharmaceutical/Biotechnology industry.

Knowledge and experience with Electronic Data Capture (EDC) system and other data management systems.

Ability to juggle multiple tasks and priorities.

Analytical and problem-solving skills, with good attention to detail.

Excellent communication skills (oral and written) and interpersonal skills.