Country Study Specialist
455 E Grand Ave., SSF44 South San Francisco, CA 94080
Bayside Solutions is seeking a Country Study Specialist (CSS) to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
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. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
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.
Country Study Specialist (CSS)
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- 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 Country Study Specialist (CSS) is responsible for providing project co-ordination and operational solutions to support Country Study Managers (CSMs). The position also provides clinical trial oversight to local study teams to enable effective management of both global and local trials.
- Coordinates/Supports operational aspect for implementation of clinical trial activities from study start-up through database lock, ensuring client qualify and safety standards, regulations, timelines, and budget commitments are met.
- Performs/coordinates protocol and site level feasibility activities, including elevation of patient population and final site selections (if applicable).
- Provides input into and/or develops study related materials such as monitoring plans, recruitment plans, and study newsletters.
- Supports/coordinators the negotiation of site budgets within fair market value (fmv) guidelines, budget pans and provides oversight for site payments per contract as required.
- Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required.
- Works with global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non-productive sites and tracking of safety procedures.
- Supports management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).
- Is responsible for the co-ordination and oversight of local affiliate study level audit/inspection audit action plan activities.
- Provides feedback to local vendor manager and CSM on CRA’ s, and local supplier/vendor performance.
- Coordinates study or country communication plan.
Summary of Qualifications:
- University degree or equivalent; professional qualification preferably in a medical/science related field and experience demonstrating knowledge and understanding of clinical trials.
- Monitoring experience is desirable.
- Previous experience managing projects is desirable.
- Ability to travel domestically and internationally.
- Ability to communication clearly and accurately in both written and spoken English.
- Technical and professional knowledge and Skills
- Uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
- Identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; chooses the best course of action by establishing clear decision criteria, generates and evaluates alternatives, and makes timely decisions; takes action that is consistent with available facts and constraints and optimizes probable consequences.
- Gains others’ confidence by action with integrity and following through on commitments while disclosing own positions; treats others and their ideas with respect and supports them in the face of challenges.
- Takes prompt action to accomplish work goals; takes action to achieve results beyond what is required; is proactive.
- Sets high standards of performance for self and others; assumes responsibility and accountability for successfully completing assignments or tasks; self-imposes standards of excellence rather than having standards imposed.
- Maintains effectiveness when experiencing major changes in work responsibilities or environment (e.g., people, processes, structure, or culture); adjusts effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successful.