Manager, Clinical Data
Thoratec Corporation - Burlington, MA

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Job Description:
Pioneering Therapies, Transforming Lives . What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. We have an incredible opportunity for a Sr Manager, Clinical Affairs to work with our Clinical Affairs group.

The Manager of Clinical Data will supervise the activities of the Clinical Data Specialists and Clinical Data Coordinators in our growing Clinical Affairs division. The position will also have responsibility for the data quality of all Clinical Affairs pre – and post-market studies. The manager will assign and carry out tasks during the clinical trial lifecycle related to database build, query resolution, database lock and reporting.

RESPONSIBILITIES:
The duties and responsibilities for this position include, but are not limited to, the following:

Supervise Data Specialists and Data Coordinators

Evaluate resources and assist Sr. Manager in resource planning and forecasting

Oversee the selection process for new data management staff

Coach and train staff to promote continuous team improvement and productivity

Establish performance goals and objectives to ensure quality of data

Assign tasks to accomplish data management goals within timelines

Perform employee performance review evaluations

Manage data management timelines for all Clinical Affairs studies

Contribute to the development and revision of data management SOPs and related documentation, such as Data Management Plans

Establish metrics to monitor study progress and performance

Participate in EDC start up activities, including CRF specifications, edit checks and validation.

Participate in all database closeout activities

MINIMUM QUALIFICATIONS:
Bachelor's degree or RN with more than five years of experience in Clinical Data Management.

3+ years people management experience

ADDITIONAL QUALIFICATIONS:
Excellent verbal and written communication skills

Experience managing multiple protocols simultaneously

Experience working with EDC and CTMS systems

Knowledge of ICH and GCP Guidelines

Strong organizational and time management skills

Analytical skills

Why work for us?

For more than 30 years, Thoratec has been committed to developing advanced medical technologies to improve patient survival and quality of life. Thoratec provides the broadest mechanical circulatory support portfolio to treat the full range of clinical needs. From acute to chronic heart failure, Thoratec offers proven device-based therapies to provide a new beginning for patients and their families. We value people who are passionate about collaboration, creativity, and quality. We give back to our community and help people live healthy lifestyles through support, education, involvement, and participation.

Thoratec employs more than 700 people worldwide. We are based in Pleasanton, California, with facilities in Burlington and Waltham, Massachusetts; Sunnyvale and Rancho Cordova, California; Cambridgeshire, UK; and Zurich, Switzerland.

Thoratec Corporation is an Affirmative Action/Equal Opportunity Employer.

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About this company
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Thoratec Corporation (Thoratec) is a manufacturer of mechanical circulatory support products for use by patients with heart failure (HF)....