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Sr. Manager Clinical Data
| Details |
Country: USA
Location: CA Fremont
Total applied: 50
Relevant Work Experience: 5+ to 7 Years
Career Level: Manager (Manager/Supervisor of Staff)
Education Level: Bachelor's Degree
Job Type: Employee
Job Status: Full Time
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Sr. Manager Clinical Data
PDL BioPharma is a commercial biopharmaceutical company that develops, manufacturers, markets and sells innovative products to address serious unmet medical needs. We are a leader in the development of humanized antibodies to prevent or treat various disease conditions. We currently have the following opportunity in our Fremont, CA location:
Sr. Manager Clinical Data Management
(4374-R)
Clinical Data Management (CDM) is a subset of Biometry that is responsible for the collection and data entry of clinical trials data into the clinical database, providing assurance that the data accurately reflects the data entered on the case report forms at the sites and documenting the procedures used in performing these functions. This position is responsible for ensuring that these functions ( data entry, verification, query resolution and documentation of the database) meet regulatory requirements and departmental SOPs and guidelines, so that the data can confidently be used as the basis for analyses and presentations to the FDA and other regulatory agencies.
Responsibilities: Task prioritization and personnel management of Clinical Data Coordinators (CDC), CRF Designer and Technical Document Specialist. Oversees the Sr. CDC who supervises the Clinical Data Assistants (CDA).Coordination of efforts between CDM and Clinical Ops/Study Site personnel regarding the conduct and operation of DataFax and associated data. Participation in CRF development.Clinical oversight and perspective of potential data patterns.Creation of reports and procedures to facilitate the timely resolution of data queries and database finalization.Selection and implementation of Quality Control procedures for Clinical Data Management.
Requirements: Must have a BS or MS in biological sciences or equivalent with 5+ years of experience in the conduct and execution of therapeutic clinical trials.A minimum of 2 years of staff management experience is required. Solid management and communication skills are essential. Experience with DataFax and GCP are highly desirable.
PDL is proud to offer a comprehensive benefits package, including medical, dental, vision and life insurance. Please apply online at www.PDL.com
Reference # 4374-R. We are an Equal Opportunity Employer.
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Biotechnology and Pharmaceutical 
