Senior Manager, Clinical Trials (7663)
Career Opportunities: Senior Manager, Clinical Trials (7663)
Requisition ID 7663 - Posted - Central - R&D - US - Bridgewater, NJ - City (112)
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.
Sr. Clinical Trial Manager
Responsibilities
- Leads or collaborates on required tasks prior to commencement of senior clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with senior clinical trial sites regarding all logistics including contract agreements, support materials and training
- Provides clinical oversight and management for senior clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies
- Communicates with vendors and senior senior clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements
- Collaborates on clinical data processing in accordance with departmental SOPs and guidelines
- Verifies, reviews and tracks CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data; ensure that data changes are properly implemented and captured in the database or data system
- Assists in the evaluation and analysis of senior clinical trial data to facilitate completion of senior clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions
- Assists in tracking study specific payments
- Provides operational or work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed
- Collaborates on project teams, primarily with Clinical Operations, Research and Development, Safety, Senior Clinical Trial Materials, Marketing, Regulatory and Quality/Compliance
- Leads or collaborates on technical writing projects which include white papers, abstracts, manuscripts, and literature reviews
- Liaison between internal and external stakeholders to facilitate cooperation of others
- Conducts presentations of clinical information concerning specific projects
- Works on projects of moderate-to-high degree of difficulty in which analysis of situation or data requires review of identifiable clinical factors and in which scientific and clinical perspectives should be incorporated
Qualifications
- Bachelor’s degree in a health profession or science. Advanced degree preferred.
- At least 5 years of on-going senior clinical trials experience in the pharmaceutical or device industry. Both is preferred.
- Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements.
- Knowledge of medical terminology.
- Ability to effectively work independently
- Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook) and data management experience.
- 10%-20% travel required.
Language and Verbal Skills:
- Individual must have good verbal skills and written skills plus a demonstrated ability to communicate clearly and professionally.
Analytical and Reading Skills:
- Ability to read analyze interpret and assist in the creation and refinement of company procedures. Ability to identify problems, collect data, draw valid conclusions, and report on findings. Ability to assist in analysis of senior clinical trial data. Ability to interpret articles published in medical and scientific journals relative to projects and activities in Clinical Programs. Responsible for ensuring accuracy of medical and scientific information.
Physical Requirements:
- While performing the duties of this job the employee may be required to perform tasks involving lifting weights of up to 30 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision. Duties will also include air travel both domestically and internationally.
This position may be available in the following location(s): US - Bridgewater, NJ
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
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Bausch Health is an EEO/AA employer M/F/D/V.