BD (Becton, Dickinson and Company) Sr. Manager, Clinical Sciences in Murray Hill, New Jersey
The Senior Manager, Clinical Sciences applies a broad knowledge of clinical research activity, therapeutic area knowledge and regulatory requirements to facilitate the development, implementation and dissemination of clinical studies. The primary objective and purpose of this position is to ensure that clinical trials are designed to meet the regulatory and business needs of the responsible Business Unit and that study documents (i.e., protocols, study reports) are developed with scientific rigor. He / she leads others in all aspects of clinical science including research, developing and writing study protocols, investigator brochures, study summaries, clinical study reports, or other clinical documents. Additionally, he / she and team will assist Medical Affairs in Business Units in developing clinical strategies and executing publication strategies. The Senior Manager, Clinical Sciences will review study protocols as requested or required and may be asked to respond or provide guidance regarding scientific and related procedural issues from investigators. He / she will oversee one or more medical writers who will provide timely and accurate completion of medical writing deliverables.
The position works closely with Medical Affairs at Business Units, Principal Investigators and statisticians to develop clinical documents. He / she may present or assist with preparing responses to regulators or present data to data monitoring committees, investigators, etc.
Additionally, he/she will collaborate and facilitate discussions with internal partners such as Health Economic & Outcomes Research, Global Health, Digital Health and others.
Works with GCD Functional Groups and Business Unit Medical Affairs and HEOR to define clinical strategy in support of business objectives;
Conducts and oversees background research on indications and studies to establish references and scientific base;
Utilizes knowledge of clinical trial design to develop specific study concepts and protocols;
Participates and leads discussions concerning scientific and procedural aspects of study design;
Develops and/or oversees the development of clinical documents (study protocol, investigator brochures, consent forms, study reports, etc.) in accordance with regulatory requirement;
Provides input to the design of CRFs;
Identifies and resolves issues related to study design and execution;
Prepares/writes and reviews/edits regulatory documents and responses to regulatory authorities (e.g., Notified Bodies, FDA, etc.) as it relates to BD-sponsored studies and/or clinical evidence;
Plans, drafts and revises scientific manuscripts for publication;
Writes and presents abstracts describing study data for clinical conferences;
Supports Key Opinion Leader (KOL) development activities as needed.
Helps develop policy and assumes the Administrator’s role for compliance with clinical trials registration to meet US and other regional laws and regulations
Identifies best practices for study design and execution, updates SOPs and templates accordingly, and provide training sessions for appropriate personnel;
Leads and develops a team of clinical scientists to support business needs;
Minimum of BS or equivalent, MS, MPH, PharmD or PhD in field relevant to clinical research preferred
Experience in clinical medicine setting, e.g., laboratory, hospital research unit
Minimum 3 years with PharmD or Ph.D, 5 years with MS or MPH and 8 years with BS.
Minimum 3 years supervisory experience.
Must be able to use scientific and clinical knowledge to conceptualize study designs
Must demonstrate excellent writing and organizational management abilities
Familiar with clinical operations and FDA and HIPAA rules, regulations and guidelines
Knowledge of good document management practices
Ability to anticipate and resolve problems
Ability to lead cross functional efforts and teams
Proficiency in data interpretation
Clinical project management skills
Excellent skills in oral and written communications
Ability to work independently with minimal guidance as well as collaboratively within a team setting
Division Name: BDI Corporate
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 730 Central Ave
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.