Sunovion Manager, Clinical Data Management in Marlborough, Massachusetts

Job Description:

Responsibile for providing comprehensive data management expertise (including all operations tasks and DMP generation, oversight and approval) while overseeing data management activities to ensure that the Project Team expectations are understood, timelines are met and quality data delivered.

Job ID: 6444BR

Department: Research & Development

Location: Marlborough, MA

Job Type: Full-time

Summary of Responsibilities: Responsibile for providing comprehensive data management expertise (including all operations tasks and DMP generation, oversight and approval) while overseeing data management activities to ensure that the Project Team expectations are understood, timelines are met and quality data delivered.

Essential Functions: • Manage all aspects of the clinical trial data management process from study start-up to database lock for Electronic Data Capture (EDC) trials.

• Serve as a member of Clinical Study Teams and act as primary Data Management contact and contributor for assigned projects.

• Oversee CROs, EDC vendors and other third-party vendors in a project manager capacity in support of timelines and data-related deliverables.

• Monitor timelines and ensures that clinical data management deadlines are met with quality.

• Perform UAT for database and test according to UAT Plan.

• Specify requirements for data management documentation, electronic and manual edit checks created by CRO.

• Review and approve electronic and manual edit checks created by CRO.

• Review and approve data management documentation created and maintained by CRO.

• Create and maintain electronic and manual edit check specifications for internal studies.

• Create and maintain data management documentation for internal studies.

• Review and provide feedback on protocols.

• Ensure adherence to data management standards.

• Provide written and/or verbal status reports to department and project team.

• Provide data management input to Requests for Proposal.

• Review vendor proposals, work orders and contracts.

• Serve as the data management subject matter expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables and resource requirements.

• Manage multiple projects.

• Identify and troubleshoot operational problems, issues, obstacles and barriers for studies based on metrics data, and input from project team members.

• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.

• Investigate, evaluate and implement new technology solutions.

Minimum Education Requirements: Bachelors

Experience Required: 7 - 10 Years

Knowledge & Skills (General and Technical): • A BA or BS degree in a health-related field preferred with 7-10 years of related experience in clinical data management in the pharmaceutical / biotechnology industry or equivalent.

• Electronic data capture/reporting experience (Rave, JReview, BOXI)and working knowledge of SDTM and C-DASH principles desirable.

• Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management.

• Strong attention to detail and ability to take ownership of complex issues, ensuring resolution.

Other Requirements (Licenses, Certifications, Specialized Training, Physical or Mental Abilities Required): • Capacity to learn and navigate through different data management systems (Inform, Rave, Oracle Clinical).

• Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management.

• Knowledge of safety data and coding using MedDRA and Who Drug dictionaries.

• Excellent interpersonal, communication, and organizational skills with the ability to work in a dynamic team environment.

• Understands and routinely considers the big picture.

• Understands

• Demonstrates project management skills.

• Must have knowledge of current industry standards and direction.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a computer for extended periods of time.

Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer

Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.