Bristol-Myers Squibb Company

Data Specifications Manager

Location
Princeton, NJ, US
Posted
Apr 13, 2018
Ref
R1121137
Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time

This is a Wallingford role that will be located in Central New Jersey.

This position supports data management activities to ensure efficiency and quality throughout startup of the clinical trial from protocol development to database in production for eCRF data requirements. Drives (with the protocol team) the completion of the study start up activities (e.g. CRF, Database Specifications, Derivations, etc.) and ensures program level standards are applied at the protocol level from study start-up to database in production.

Summary:

This position supports data management activities to ensure efficiency and quality throughout startup of the clinical trial from protocol development to database in production for eCRF data requirements. Drives (with the protocol team) the completion of the study start up activities (e.g. CRF, Database Specifications, Derivations, etc.) and ensures program level standards are applied at the protocol level from study start-up to database in production.

Primary Responsibilities:

• This position supports data management activities to ensure efficiency and quality throughout startup of the clinical trial from protocol development to database in production for eCRF data requirements.
• Drives (with the protocol team) the completion of the study start up activities (e.g. CRF, Database Specifications, Derivations, etc.) and ensures program level standards are applied at the protocol level from study start-up to database in production.
• Collaborates with the Data Lead to develop standards and ensure consistency and efficiency of the clinical protocols within indication or program for study startup standards and documents.
• Drives and owns the timelines and associated deliverables and serves as the Global Standard Subject Matter Expert at the study and TA level.
• Identifies any new data types and develops them in conjunction with key stakeholders (e.g., MM, GBS, Global Standards);
• Oversees the data collection deliverables for eCRF. Drives the development of the RAVE database in collaboration with data base designer and Global Biometric Sciences.
• Reviews the protocol to identify data collection needs. Remains critical to the protocol development and review process to ensure the most efficient data collection strategy is implemented.
• Develops new data collection modules following the New Build Process.
• Finalizes the Data Specifications Package, which include the electronic Case Report Form (eCRF), visit schedule and Non-cleaning edit checks, derivations and custom functions.
• Assists with vendor relations (e.g., CRO; CCL) as needed to support the incumbent's project(s).
• Performs reviews and updates to current documentation to align with new processes/systems
• Leads cross functional teams or initiatives.

Qualifications:

• Masters or Bachelors degree (BS or MS)
• Medidata RAVE experience
• 3 to 5 years of clinical data management or related experience
• 1 to 3 years of experience in CRO management in the pharmaceutical industry.
• Strong understanding of science and health
• Requires strong leadership skills
• Requires strong interpersonal, communication, planning, organization, negotiation, influencing, collaboration and presentation skills.