620 E Grand Ave., SSF45
South San Francisco,
Industry: Clinical & Scientific
Job Number: 16408
Bayside Solutions is seeking a Country Study Manager 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 Manager
- 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 CSM provides Leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with the client’ s quality standards, all applicable regulations, timelines and budget commitments.
- For Global/Regional Studies (referred as Global), the CSM leads and has full accountability (time, quality, cost) in alignment with Study Management Team (SMT).
- For Local Studies, the CSM acts as study leader and, in addition to the above provides the leadership and clinical operational expertise for the local study team.
- Full accountability and oversight for all assigned studies at regional/country level (Global and Local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans (e.g. timelines, budget, resources, risk and quality plans) in the appropriate client planning system
- Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
- Lead local study teams, represents Country/Region Clinical Ops at the global SMT, and provides Global Teams with feedback from an affiliate perspective (Global)
- Plans and executes country study goals and commitments, and secures compliance to relevant processes.
- May serve as global Country Study Representative (gCSR), as part of global study team
- Coaches and provides support to responsible study team members
- Provides study oversight, leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as requires.
- Oversees study feasibility, site monitoring performance, preparation of Risk Bases Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
- Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
- Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future studies.
- Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g landscaping activities, investigator/site development activities or affiliate cross functional teams etc.), as required.
Summary of Qualifications:
- University degree or equivalent; preferably in a medical/science- related field and extensive experience and expertise in clinical research/development or related industry. Extensive experience in clinical trial project management.
- Availability to travel domestically and internationally is required.
- Decision Making – identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints, and optimizes probable consequences.
- Planning and Organizing (Achieving Results/Strategic Agility) – establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines and leveraging resources.
- Must be a strong communicator, written and verbal
- Ability to build partnerships – teamwork and collaboration are a must to leverage relations within and across the work group
- Effective involvement and persuasion strategies to influence and inspire.
- Engages individuals in developing and committing to an action plan by coaching and giving feedback.
- Sets high standards of performance for self and others; assumes responsibility and accountability for successfully completing assignments or tasks.
- Creates novel solutions with measurable value for existing and potential customers (internal and external) experiments with new ways to solve work problems.
- Works effectively with individuals of diverse cultures, interpersonal styles, abilities, motivations, or backgrounds; seeks out and uses unique abilities, insights, and ideas from diverse individuals.