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.
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
Bachelor's degree or RN with more than five years of experience in Clinical Data Management.
3+ years people management experience
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
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.
Thoratec Corporation - 2 years ago
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Thoratec Corporation (Thoratec) is a manufacturer of mechanical circulatory support products for use by patients with heart failure (HF)....