Global Studies Manager
455 E Grand Avenue South San Francisco, CA 94080 | Contract
Bayside Solutions is seeking a Global Studies 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.
Global Studies 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:
- Provides direction and leadership to one or more clinical operations teams.
- Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
- Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
- Contributes to the development and management of the study timelines, resources, budget, risk and quality plans.
- Provides clinical operations expertise to ensure operational feasibility and delivery.
- Oversees forecasting of clinical/non-clinical supplies.
- Delivers the operational elements of the study plan.
- Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work.
- Identifies areas of best practice and process improvements.
- Ensures study adherence to ICH/GCP and SOPs.
Summary of Qualifications:
- Life sciences degree or nursing equivalent and 5-7 years of experience as a Global Studies Manager in a clinical research/a healthcare environment.
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
- Good knowledge of ICH GCP.
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Experience of working as a part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.
- Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.