Manager/Sr. Manager, Clinical Data Management

Requisition ID: 324

Position Summary

The Manager/Sr. Manager of Clinical Data Management will support the Data Management group from study start-up through database lock and clinical study report. The successful candidate will deliver high quality data, on time and on budget. In this role, the candidate will be expected to lead and provide oversight for the execution of data management activities for more than one compound in a therapeutic area. This role will report to the Associate Director, Clinical Data Management.

Responsibilities

• Interacts with project leaders and other internal and external stakeholders to ensure adequate support of clinical projects and systems
• Contributes to departmental development projects to improve quality, effectiveness and efficiency, including standards development
• Collaborates with cross-functional department leads in the design and implementation of procedures, systems and standards
• Contributes to the strategy of CDM
• Manages studies and/or individuals, vendors, as applicable
• Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data
• Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards; including conducting and managing internal data quality reviews
• Partners with clinical study team to create and validate database design, edit check specifications, data transfer specifications, and clinical listings and reports
• Contribute in the development, revision and review of CDM SOPs, guidelines and Work Instructions
• Maintains an ongoing focus on industry trends regarding opportunities and challenges; reports on issues identified in order to improve and develop department strategy with third parties regarding service levels - including CROs and other vendors
• Performs other duties as assigned

Qualifications

• Bachelors or graduate level degree in Life Sciences, or similar
• 5+ years working experience in Data Management in pharmaceutical or CRO setting
• Strong experience with EDC (Rave preferred), full development life cycle
• Well-rounded technical skills: EDC, SAS, and CDISC
• Working experience handling lab/image data
• Strong understanding of clinical trials, pharmaceutical operations, and regulatory compliance
• Practical knowledge of ICH, FDA, and GCP regulations and guidelines
• Accuracy and attention to detail working with clinical data
• Good planning, project management and organizational skills
• Good people management skills
• Excellent written and oral communication skills

Portola Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.