Associate Clinical Trial Manager
Proclinical is currently recruiting for an Associate Clinical Trial Manager with a pharmaceutical company located in Redwood City, CA. A success candidate will have experience with clinical operations and vendor management. A bachelor's degree is a must.
- Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
- May contribute to SOP development.
- Provide administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- May 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.
- 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.
- Participate or effectively run meetings and conference calls with CROs, vendors, and multi-functional teams.
- 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.
- May participate in abstract presentations, oral presentations and manuscript development.
- Interface with individuals in other functional areas to address routine study issues.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- May be asked to assist in the training of CTMAs and CPAs.
- Assist in CRO or vendor selection.
- Coordinate CROs or vendors.
- Assist in the setting and updating of study timelines.
- May participate in departmental or interdepartmental strategic initiatives under general supervision.
- Assist in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- May conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required.
- Assure site compliance with the protocol and regulatory requirements.
- Draft and coordinate review of protocols, informed consents, case report forms and monitoring plans
Skills and Requirements:
- 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.
- Experience in Clinical Operations and a degree in a relevant scientific/medical discipline.
- Must be familiar with routine medical/scientific terminology.
If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.
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.