Senior Clinical Trial Specialist
300 Bel Marin Keys Blvd. San Rafael, CA 94901
Bayside Solutions is seeking a Senior Clinical Trial Specialist to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.
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.
Senior Clinical Trial Specialist
- 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:
- The ideal candidate would be a clinical research professional passionate about operations with up 4 years’ experience in Clinical Operations, focused on working to ensure delivery of quality data, and committed to helping our patients.
- A proactive problem solver who shows flexibility and an ability to communicate efficiently.
- The Sr. Clinical Trial Specialist (Sr. CTS) performs essential responsibilities for successful trial execution.
- He/She takes on the key role of Study Specialist in the operational team, contributing to, or leading tasks related to study management and oversight activities. This may include contributing to and/or supporting study matters that impact study timelines, quality and budget.
- Following demonstrated success in the Study Specialist role, the Sr. Clinical Trail Specialist may have the opportunity to take on regional operations responsibilities including managing issues and opportunities that impact regional study timeline, quality and budget; overseeing the CLO team, vendors and CRO for the study in the region; and escalating regional decisions, issues and risks.
- Key responsibilities for this position include:
- Manage and track vendor adherence to SOW and oversight plan for assigned vendors
- Lead protocol deviation meetings, if assigned
- Contribute to or be responsible for the development of vendor specific timelines ensuring alignment with study level timelines
- Manage Change Order and Change Negotiation Form (of vendors) processes, in collaboration with Business Operations
- Review and approve invoices for assigned vendors
- Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing
- Drive day-to-day management of assigned vendors
- Communicate study performance expectations to vendors, manage and track vendor performance metrics at a study level
- A diverse set of operational responsibilities related to the startup, the conduct and the close-out of clinical trials
- BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
- 4+ years pharmaceutical industry experience
- The Senior Clinical Trial Specialist is expected to have foundational competence in critical areas such as Communication and Problem solving.
- Expected to be proactive and able to make decisions. For example:
- Responds promptly with clear, organized written and oral communication
- Seeks out, and understands the value of, opportunities to interact with peers and stakeholders; builds a network of internal and external peers
- Takes ownership and accountability for completing assigned tasks and perseveres through obstacles
- Embraces new challenges or changed priorities and adjusts plans and priorities accordingly
- The Senior Clinical Trial Specialist has foundational technical competence in Study Management and Execution, Compliance and Quality, Drug Development and Study Design, and Product and Therapeutic Area Knowledge.