Summary of Position with General Responsibilities:|
The Clinical Scientist serves a medical research function and applies a broad knowledge of clinical research activity, therapeutic area knowledge and regulatory requirements to facilitate the development and implementation of clinical studies. The primary objective and purpose of this position is ensuring that clinical trial protocols and study reports are developed and written with scientific rigor. He / she is responsible for all aspects of clinical science including research, developing and writing study protocol, investigator brochures, study summaries, clinical study reports or other clinical documents. The Clinical Scientist will oversee the scientific aspects of clinical studies throughout the duration of the study and may be asked to respond or provide guidance to address questions regarding scientific and related procedural issues from investigators. He / she will support clinical teams as the medical writing representative, bearing the responsibility for timely and accurate completion of medical writing deliverables.
The Clinical Scientist works closely with Divisional CA, Bard Corporate, Principal Investigators and biostatisticians to develop clinical documents. He / she may present or assist with preparing responses to regulators or present data to data monitoring committees, investigators, etc.
Essential Job Functions:
Conduct background research on indications and studies to establish references and scientific base;
Utilize knowledge of clinical trial design to develop specific study concepts and protocols;
Participate in protocol review discussions concerning scientific and procedural aspects of study design;
Develop clinical documents (study protocol, investigator brochures, consent forms, study reports, etc) in accordance with Bard STDS and relevant regulations;
Provide input to the design of CRFs and Statistical Analysis Plans;
Identify and resolve issues related to study design and execution;
Assist with the ongoing review of summary data including safety, primary efficacy variables and lab data;
Assist in the preparation and review of key regulatory documents, submissions, and annual reports. Present clinical performance data to regulatory officials.
Plan, draft and revise scientific manuscripts for publication;
Write and present abstracts describing study data for clinical conferences;
Support divisions with posting of protocols, study results and adverse events on ClinicalTrials.gov
Additional Desirable Qualifications Skills and Knowledge:
- Minimum of BS or equivalent, MS, PharmD or PhD in field relevant to clinical research preferred
- Hospital training preferred
- Minimum 3 years with PharmD or Ph.D, 5 years with M.S. and 8 years with BS.
- Must demonstrate excellent writing and organizational management abilities
- Expert ability in Microsoft Word, Power Point and Excel as well as scientific graphing applications
- Familiar with clinical operations and FDA and HIPAA rules, regulations and guidelines
- Knowledge of good document management practices
Ability to use scientific and clinical knowledge to conceptualize study designs
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
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...