Clinical Data Manager (temp)

at  Cerus Corporation

About Cerus:
Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.
This is a temporary opportunity from April to November.
Summary & Scope of Position:
Provide quality management of clinical trial data in a rapidly evolving environment.

Primary Responsibilities:

• Lead data management activities including Case Report Form (CRF) designing, database designing, developing Data Management Plan, CRF annotation, implementing edit check programs, data entry and query status tracking, and database closure.
• Work closely with cross-functional teams (e.g., Statistical Programming, Biostatistics, Clinical, CRAs, Safety) to support the set-up, conduct, and closure of clinical studies from aspects of data management.
• Create, review, or modify study specific data management documents as needed.
• Generate, resolve, and track queries as needed to resolve erroneous, incomplete, or implausible data.
• Work with CROs to implement clinical data management process (e.g., data quality review, following up on findings from edit checks, query management).
• Lead and coordinate EDC User Acceptance Testing (UAT) efforts.
• Utilize standard or customized reports to track study progress and ensure timeliness and quality expectations are met.

Qualifications/Requirements/Skills:

• Bachelor’s degree with a minimum of 2 years experience in Clinical Data Management and 5 years at a pharmaceutical/biotechnology company or Contract Research Organization.
• Experience leading the database lock of a clinical study preferred.
• Understand the principles of clinical research, GCP (Good Clinical Practices) and GCDMP (Good Clinical Data Management Practices)
• Working knowledge of SAS or SQL preferred.
• Computer literacy with competence in MS Word and Excel.
• Working experience with Excel associated with conditional formatting, complex formula, and macros a plus.
• Logical thinking, attention to detail, good organizational skills, and problem-solving abilities.
• Ability to effectively communicate and make department level presentations, both in writing and verbally.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

• Lead data management activities including Case Report Form (CRF) designing, database designing, developing Data Management Plan, CRF annotation, implementing edit check programs, data entry and query status tracking, and database closure.
• Work closely with cross-functional teams (e.g., Statistical Programming, Biostatistics, Clinical, CRAs, Safety) to support the set-up, conduct, and closure of clinical studies from aspects of data management.
• Create, review, or modify study specific data management documents as needed.
• Generate, resolve, and track queries as needed to resolve erroneous, incomplete, or implausible data.
• Work with CROs to implement clinical data management process (e.g., data quality review, following up on findings from edit checks, query management).
• Lead and coordinate EDC User Acceptance Testing (UAT) efforts.
• Utilize standard or customized reports to track study progress and ensure timeliness and quality expectations are met