Country Studies Manager
South San Francisco, CA | Contract
Bayside Solutions is seeking a Country Studies Manager to be part of our Client’ s team in South San Francisco. This is an opportunity to work with a local Biotechnical company focusing on the discovery, development, manufacturing and commercialization of medicines to treat patients with serious or life-threatening medical conditions.
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 atwww.baysidesolutions.com.
Country Studies Manager
Provides leadership to one or more Local Study Teams (LSTs) and provides local strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the affiliate portion of a study and ensures the effective and efficient delivery of country/region operational aspects in accordance with the study development plan and ICH/GCP standards, local operating guidelines and local regulatory requirements. The CSM also ensure the development and maintenance of productive relationships with our customers.
- 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:
- Builds effective, high performing LSTs through influence, integrations, motivation and optimization of team performance. Embeds the Company values into the team(s) culture and promotes the team spirit.
- Sets the LST goals and ensures goals are in line with the operational strategy agreed by Clinical and Study Management Teams. Provides coaching to the team to facilitate the setting and achievement of goals.
- Liaises with other functional groups to ensure the LST(s) members and monitors receive appropriate therapeutic areas and study specific training.
- Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, e.g. Pharma Business, GSOM, functional management.
- Maintains awareness of external clinical research practices to ensure the LST(s) and monitors are aware of the risks, priorities, value and impact of their work and contributions.
- Establishes Study Timelines, Budget, Resource, Risk and Quality Plans.
- Leads and or organizes (or assists in organizing) and/or participates in local or regional meetings and training sessions (i.e. LST meetings, Investigator Meetings, Monitors Workshops and CRO training).
- Monitors progress against LST goals and take appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams.
- BS/BA or equivalent in a medical/science related field and or 5 years proven experience in Clinical Research/Development or related industry.
- Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans.
- Strong leadership skills developed through leading multi-functional matrix study teams through all stages of clinical studies.
- Proven clinical development experience on the operational aspects of conducting clinical studies including vendor/CRO management leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local business units.