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Director, Data Management

Portola Pharmaceuticals, Inc.

Location:
South San Francisco, CA
Posted Date:
7/25/2014
Position Type:
Full time
Job Code:
Director, Data Management
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biostatistics, Clinical Data Management, Clinical Research, SAS,

Job Description

Portola Pharmaceuticals Inc., is a biopharmaceutical company focused on the discovery and development of the novel therapeutics for the treatment and prevention of severe cardiovascular diseases. With one of the most experienced discovery and development teams in the areas of vascular thrombosis and inflammation, Portola is applying an integrated discovery and development approach to a comprehensive understanding of platelet physiology and vascular thrombosis, with an eye toward developing new therapeutics where current antithrombotic therapies are inadequate.

The Director of Data Management has overall responsibility for the data management function at Portola. The successful candidate will develop and implement a vision for data management at Portola. The data management function will be responsible for all aspects of data acquisition and storage, from the development of case report forms, though the final study report and subsequent regulatory needs, with emphasis on delivering data on time and on budget.

In addition to contributing to the development of your department strategy, Directors for Portola demonstrate skills, knowledge and experience in the following areas -

• Responsible for planning and growing a department to lead all clinical data management activities at Portola. Including managing and coordinating the activities of the data management group, providing technical leadership and enforcing best practices
• Ensure the data collected meets the requirements of the study objective and company quality standards
• Ensure that the data management group is aligned with business objectives and complies with FDA requirements
• Identify suitable vendor(s) for outsourcing data management activities and coordinate the review and approval of the Master Services Agreement
• Work closely with and oversee vendors to prepare and execute data management plans; manage data management projects from beginning to end
• Work closely with clinical operations group, statisticians, statistical programmers and other staff to develop CRFs to ensure the required information for statistical analysis is collected accurately
• Coordinate with statisticians and statistical programmers to create and validate database design and edit check specifications
• Communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs
• Oversee hiring, daily management, training and development of data management staff
• Ensure coding of safety data is accurate using industry standard coding conventions
• Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data
• Develop and update SOPs associated with the data collection, handling and review processes to meet regulatory compliance and operational needs; assist by reviewing SOPs from other departments as they affect the data management function
• Assist with the validation of the statistical output for final reports

Requirements

• A Bachelor’s or equivalent
• A minimum of 13 to 16 years of experience with at with at least 10 years of demonstrated success in a management role and clinical research data handling environment with relevant practical experience in protocol review/CRF design, clinical study databases and data management
• Knowledge of database structure and programming required
• Knowledge of SAS software and its application in data management is a plus
• Working Knowledge of CDISC standards including expertise in CDASH
• Excellent organizational and leadership skills with ability to manage staff, projects and resources to meet timelines and budgets in a fast-paced environment
• Effective problem solving, collaboration and strong teamwork skills
• A vigilant commitment to proactive problem solving
• Accountability for the performance and development of employees and the achievement of individual, department and company goals
• Appropriately inform and escalate risks upward
• Demonstrates excellent leadership ability
• Amount of travel: Currently up to 5%

Contacting Us:
• Our company overview and history: http://www.portola.com/Company-Overview
• This position requires candidates to provide examples of programming in a clinical data setting
• Please include a cover letter that highlights your qualifications and matches our requirements and send resumes to careers@portola.com
• Recruiters: Please click this link for more information: http://www.portola.com/Recruiters-and-Vendors

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