Project Data Manager

Biopharmaceuticals

At Bayer HealthCare Pharmaceuticals we take pride in knowing that our work is an affirmation of life. It stems from our commitment to advance patient care and to shape the future of medicine. It also connects us to the many lives we serve in the Women’s Healthcare, Oncology, Diagnostic Imaging, and Neurology markets. We are a global research-based pharmaceutical company and our purpose is to bring diagnostic and therapeutic innovations to the healthcare community. With a vast global network and a robust product pipeline and U.S. revenues exceeding $2.6 billion, we offer the opportunity for career fulfillment and the chance to make life the best it can be.

 

Plan, organize and supervise Data Management activities for studies allocated to local staff. Ensure global clinical data management best practices and knowledge thereof in a standardized, transparent, and efficient manner. Assume responsibility as a partner for the planning, resourcing, and execution of relevant internal and external data management activities.

 

Act as a study data manager in assigned studies, i.e. manage Study Data Management Teams and assume operational responsibility

Ensure adequate application of global clinical data management best practice for all assigned studies

 

Ensure the adequate support of clinicians in medical.

 

Contribute to the preparation of data monitoring plans (coordinate amongst Study Teams, Global Medical Surveillance, Drug Safety Monitoring Boards, Authorities and Ethics Committees) for all assigned studies

 

Ensure the availability of protocol deviation documents for all assigned studies

 

Support maintenance of project and therapeutic area standards (CRFs, eCRFs, data structure, listings, edit checks, derivations, code lists, instructions for handling) and consistency in co-operation data management counterparts. Negotiate and communicate above standards with counterparts in neighboring functions such as the Statistics function.

 

Ensure appropriate medical coding within studies and application of global and project standard coding rules and conventions for all assigned studies

 

Ensure adequate documentation of all activities within the sub-function for all assigned studies. Position is based in Fairfield, NJ



 Bachelor's Degree in a health science or Informatics, 8 + years of experience, of which  2 + years were as a Study Data Manager; or equivalent. Alternatively incumbent must have a Masters degree and 6 years of experience. Experience in either case includes a understanding of medical terminology, disease states, encoding systems (i.e. MedDRA, WHO-DD, microorganism classification, etc.) and an understanding of regulations and guidelines (i.e. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPPA]). A solid understanding of database theory and experience in using data management methodologies and technologies (e.g. data computerization, storage and retrieval methods, electronic data capture) in the set-up, conduct and closeout of clinical studies is required. Working knowledge of at least one industry-relevant relational database application/CDMS (e.g., ClinTrial, Oracle Clinical, etc.) and/or EDC application is required. Demonstrated use of at least one data review tool/programming language (e.g., SAS, PL/SQL, SQLPlus, iReview/jReview) for development and generation of data listings, ad hoc queries, data tabulations and status or system reports is desired. Incumbent must understand information flows in clinical development. Effective oral and written communication skills are essential. Incumbent must possess excellent interpersonal relationship skills and be able to interact with individuals across all levels of Global Clinical Organization, Medical, Statistics, and the global community in order to successfully complete assignments. Incumbent must possess proven self management skills in addition to ability to coordinate local resources.





As a member of the Bayer HealthCare Pharmaceuticals team, you'll find an environment that celebrates diversity and welcomes the open exchange of ideas and individual perspectives. We are proud to offer an attractive salary along with a generous benefits package designed to support the needs of you and your family while addressing work/life balance issues. To learn more about Bayer HealthCare Pharmaceuticals or to apply online, please visit our website at pharmajobs.bayerhealthcare.com. EOE/AA/M/F/D/V