Program Clinical Data Manager at ABIOMED Inc. in Danvers, Massachusetts

Job Description:

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission ofRecovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

Patients First | Innovation | Winning Culture | Heart Recovery

The Program Clinical DataManager (CDM) will lead all data management activities for Abiomed sponsored studies throughout the clinical study lifecycle including start-up, maintenance and completion activities. The primary objective of this position is to ensure clinical study data are collected, handled and validated in an appropriate and consistent manner to ensure a high-quality database is delivered for statistical analysis within agreed upon project timelines. In addition, the Program CDM will be looked upon to standardize process and implement best practices in an effort to improve quality and streamline data collection/validation efforts. She/he will demonstrate an advanced knowledge of database applications, data management best practices and industry standards to strategically approach delivery of data management services. The Program CDM will perform and or oversee the following activities: development of electronic Case Report Forms (eCRFs), development of database specifications, development of Data Management Plan (DMP) including electronic edit checks and Data Handling Guidelines, development of Coding Guidelines, development of Core Lab and external data specifications, conduct data review, query generation/resolution, and data reconciliation She/he will work on insourced studies as well as engage and work closely with CROs and Vendors that execute the data management and Core Lab services.

Principle Duties and Responsibilities:

• Lead all data management activities for assigned clinical studies, insourced and/or outsourced.


• Oversee and manage DM related activities (which may be outsourced to DM Vendors) as well as other external data sources from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time, within budget, and aligned with quality standards.


• Provide input into study protocols to ensure the data collection requirements are clear and supportive of the study endpoints.


• Drive the development of high quality eCRFs in consultation with a cross functional team that accurately reflect the data collection requirements defined in the study protocol and that are consistent with internal standards.


• Oversee database design activities to ensure it meets requirements for the entry and reporting of clinical data.


• Develop/Review Data Management Plan (DMP) and associated appendices to ensure data quality and integrity.

Job Qualifications:

• Bachelor's degree from an accredited university required; BS preferred in Life Sciences, Nursing, Computer Sciences, Data Science/Analytics, Mathematics, or related medical/scientific field. Preference will be given to candidates/individuals with a Master's degree in said disciplines.1


• Minimum of eight years data management experience in CRO, pharmaceutical, biotechnology, or medical device industry1.


• Extensive knowledge of clinical data management systems, including prior knowledge and experience with Medidata RAVE required.


• Experience with other Medidata platform applications including TSDV, Imaging (MMI), RTSM, TSDV, and CTMS desired.


• Experience with Veeva Vault electronic Trial Master File (eTMF) desired.


• Advanced knowledge of JReview, Business Objects and/or other industry reporting tools required.


• CRO/vendor management experience desired.


• An equivalent combination of education, experience and performance may be considered.

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.