Clinical Trial Manager
10260 Bubb Road Cupertino, CA 95014
Bayside Solutions is seeking a Clinical Trial Manager to be a part of our partner’ s team in the South Bay Area.
Our partner’ s culture is professional and hard working. They foster longevity and stability within their organization.
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.
Clinical Trial Manager
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Participate in all aspects of clinical trials including study start-up activities through close-out.
- Develop and track overall study budget.
- Provide project planning updates to ensure adherence to timelines
- Communicate regularly with clinical investigative site personnel, (including study nurses, coordinators, and physicians), contract research organizations (CROs) and internal key personnel to ensure clinical project goals are achieved within the team goals and according to SOPs.
- Visit clinical sites and CROs whenever needed.
- Review and approve CRA staff assignments proposed by CROs.
- Ensure compliance with protocol and project guidelines as well as GCP/ICH Guidelines, consistency w/ Sponsor and CRO SOPs.
- Responsible for participating in program specific weekly teleconferences with CROs.
- Escalate project issues to the attention of the Clinical Operations Director as well as the Medical Monitor/Project Physician in a timely fashion.
- Track the day-to-day progress of clinical site activities and updates the appropriate parties.
- Participate in editing and review of clinical study protocols and investigator brochures as needed.
- Review regulatory documents and/or regulatory checklists to ensure completeness prior to study site initiation and study drug delivery.
- Regular review of monitoring reports, EDC screens, data queries, data query resolutions to ensure protocol compliance.
- Perform ongoing data review to ensure safety and high quality data collection, for accuracy and completeness.
- Review qualifications of investigators and site staff and make recommendations for their participation in a clinical study.
- Review of Trial Master Files prior to archiving.
- Coordinate the shipment of study supplies to trial sites as needed.
- Work with Clinical Ops team to manage vendor and site budgets
- Support various needs required by regulatory applications and submissions.
- Update SOPs for Clinical Operations when required
- Participate in editing and review of documents such as clinical study protocols, clinical study reports, investigator brochures and documents required in regulatory submissions as needed.
- Contribute to verifying accurate navigation of hyperlinks within the eCTD format to insure submission readiness.
- Other tasks or projects as assigned based upon company needs.
- Undergraduate degree or RN/BS Degree in Biological Sciences, Biomedical Sciences or related field.
- Must have knowledge of Good Clinical Practices (GCP) and FDA Guidelines and Regulations
- 7+ years of Clinical Research experience for Senior level role
- Prior experience managing CROs and vendors.
- Proficient report writing (e.g., meeting minutes, monitoring reports, evaluation reports, letters to sites or vendors) and verbal reporting
- Strong computer skills (Word, Excel, PowerPoint)
- Must be able to work independently and as part of a team with high degree of professionalism
- Ability to effectively and professionally communicate (written and verbal) at all levels
- Must have keen sense of urgency and time management skills to convey critical issues to supervisor and/or Clinical Development Team
- Some work is performed in a typical office work environment and some work in a clinical environment
- Occasional travel required