Clinical Trials Manager III
280 East Grand Avenue South San Francisco, CA 94080 | Direct Hire
Bayside Solutions is seeking a friendly, energetic and hardworking Clinical Trials Manager III. This is a unique opportunity to join a growing team of business professionals focused on treatments to help individuals with diseases that affect the functionality of an individual.
Under the supervision and guidance of the Associate Director, Clinical Operations, the Clinical Trials Manager III will provide key clinical support for the management, operation, and execution of multiple clinical trials.
The culture is based on the idea of others. They pride themselves in their commitment to finding cures that other biotech companies have not tackled
Our Company Bio:
Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- Offers their employees a great work/life balance.
- Competitive compensation
- This position is eligible for medical, vision, dental benefits, paid sick time and 401k.
Summary of Responsibilities:
- Independently manages various activities associated with multiple clinical studies in accordance with designated project assignments.
- Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct.
- Has had experience as a clinical operations leader on a significant Phase II or Phase III program.
- Provides significant contributions as part of the clinical protocol development team.
- Independently creates and/or oversees the design of study related documents including but not limited to: case report forms, case report form completion guidelines, study manuals and project tools, monitoring plans, tracking tools, informed consent forms.
- Support of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directed.
- Leads study management team meetings and teleconferences with study vendors.
- Manages study-specific CROs and vendors and contract CRAs as appropriate.
- Prepares and presents study-specific slide presentations during Investigator Meetings.
- Performs independent monitoring of sites as required by needs of project.
- Attends scientific meetings as a representative of Company’ s clinical operations team.
- BA/BS in science-related field with 5-8 + years’ work experience as a CRA or CRA/CTM combination of relevant related work experience.
- Excellent written and verbal communication skills required.
- Demonstrated thorough understanding of FDA regulations and GCP.
- Well-developed strong problem solving skills.
- Exceptional interpersonal skills with demonstrated successful team participation.
- Demonstrated skill in managing multiple tasks simultaneously, with attention to detail.
- Proficient in use of Microsoft applications such as Word, Excel, Power Point, etc.
- Ability to travel important as the position could require approximately 25% time spent in business travel.