Clinical Trial Management Associate
Proclinical is currently recruiting for a Clinical Trial Manager Associate with a global biopharmaceutical company located in Redwood City, CA. As the Clinical Trial Manager, you will assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
- Contribute to SOP development.
- Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required.
- May resolve routine monitoring issues.
- Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
- Participate in abstract presentations, oral presentations, and manuscript development.
- Interfaces with individuals in other functional areas to address routine study issues.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- Assists in CRO or vendor selection.
- Coordinates CROs or vendors.
- Assists in the setting and updating of study timelines.
- Conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required.
- Participate in departmental or interdepartmental strategic initiatives under general supervision.
- Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- Assures site compliance with the protocol and regulatory requirements.
- Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
Skills and Requirements:
- 3+ years of experience in Clinical Operations and a degree in a relevant scientific/medical discipline (e.g., BA, BS, RN). Excellent verbal, written, interpersonal and presentation skills are required.
- Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
- Working knowledge and experience with Word, PowerPoint and Excel.
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Must have a general understanding of functional issues and routine project goals from an organizational perspective.
- Must be familiar with good documentation practices and electronic trial master file system.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
- Must be familiar with routine medical/scientific terminology.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.