Job Abstract

Category

Clinical Development

Position Type

Regular

Job Location

Hybrid

The Principal Data Manager oversees and coordinates all Data Management (DM) activities ensuring compliance according to quality standards, regulatory requirements, and project budget from study start-up through study close-out and final reporting.

The key duties and deliverables of this position include collaborating with the Biostatistics, Clinical and Medical Affairs teams in all aspects of supervising the CROs by setting up, managing and completing trial databases and CRFs within timelines with the primary goal of ensuring data integrity.

Additional responsibilities include assisting and working collaboratively with our Shionogi Japanese Biometrics group in the development of global and local Data Management department standard working practices.

• Manage all aspects of data management tasks for multiple studies and oversee CROs.
• Provide oversight to the planning, execution, collection and handling of all clinical data to the highest quality standards.
• Partner with cross functional groups on trial designs, timelines, vendor selection and CRO oversight.
• Design CRFs and write CRF Completion Instructions.
• Develop data management plans, edit check specifications, and data review plans.
• Perform User Acceptance Test.
• Perform SAE reconciliation with the safety database.
• Perform third party data reconciliation and liaise with vendors for issue resolution.
• Write/resolve queries and track their status.
• Conduct review of clinical trial data and perform all tasks required for database lock.
• Manage database close out activities.
• Provide trial-related support to cross functional groups such as Biostatistics, Clinical, etc.
• Develop and apply consistent Data Management standards through working practices and SOPs.
• Project management for Data Management deliverables as required.
• Attend meetings and report on study status, metrics, timelines, etc.
• Perform other data management related activities as required.

Supervisory | Decision-Making Authority

• This position entails acting as a Project Data Manager on major company programs and Trial Data Manager on key trials; this position also entails partnering with cross functional groups and decision making responsibilities regarding trial database and CRF designs, timelines, vendor selection, CRO oversight as well as general strategy for Global Clinical Data Management.
• A limited number of contract DM support staff will report directly to the Principal Data Manager.

Minimum Job Requirements

• BA/BS in science related field.
• 10+ years of data management experience in the pharmaceutical or biotechnology industry.
• Demonstrated working knowledge of data management systems and scientific principles.
• Solid knowledge of clinical trial process and knowledge of FDA regulatory requirements.
• Knowledge of CDASH, SDTM and medical terminology.
• Good working knowledge of ICH/GCP regulations and guidelines.
• Prior experience with EDC systems.
• Strong time management, organization and project management skills.
• Attentive to detail, flexible, and open to suggestions.
• Team player with excellent verbal, written and interpersonal communication skills.
• Prior experience overseeing CRO.
• Supervisory experience leading support staff.

Essential Physical Requirements

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.