Global Clinical Trial Leader
475 E Grand Ave., SSF42 South San Francisco, CA 94080
Bayside Solutions is seeking a Global Clinical Trial Leader 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 Clinical Trial Leader
- 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 Clinical Trial Leader (cCTL) is accountable for the strategic planning and execution of assigned early development global clinical trials (includes First-in-Human, Phase Ib, and other signal-seeking Phase I trials, and evidence of activity, proof-of-concept, dose-ranging, dual New Molecular Entity (NME), and other types of Phase II trials) under the direction of the Sr. Global Clinical Trial Leader (Sr. CTL)).
- The cCTL is a member of one or more cross-functional Protocol Execution Teams (PETs). These complex programs focus on the rapid development of NMEs with limited clinical data, and as such, require implementation of novel and highly flexible global operational strategies to support exploratory hypotheses, including biomarkers and diagnostics.
- The cCTL enables the efficient delivery of global clinical studies, under the leadership of the Sr. CTL.
- Key roles and responsibilities include, but are not limited to:
- Serves as a member of one or more global cross-functional Protocol Execution Team(s) (PETs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the clinical development plan:
- Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central / specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker / sample management plans, TMF, and CSRs. Liaises with cross-functional team members including the PET members to solicit input.
- Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial/medical monitoring, TMF.
- Ensures TMF creation and QC completion.
- Supports EDC and CTMS systems and data maintenance.
- Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.
- Provides strategic operational input on protocol feasibility.
- Provides input to the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution to Protocol Execution Team Lead (PETL).
- Participates in selection of vendors (participates in the Request for Proposal (RFP) process), on a global scale, in collaboration with the PETL.
- Utilizes outputs from operational analytical tools to enhance and improve study execution.
- Oversees delegated outsourced activities to ensure CRO and vendor delivery against contracted scope of work.
- Coordinates planning and execution of effective investigator meetings. May be accountable for driving agenda and content for investigator meetings.
- Stays current on relevant therapeutic knowledge and clinical research best practices.
- Ensures accuracy and timeliness of CTMS, timeline planning tools and other core systems.
- Ensures study adherence to ICH/GCP and SOPs.
Summary of Qualifications:
- Bachelor’ s degree or equivalent required (scientific or healthcare discipline preferred).
- 5+ years of study management experience in clinical and drug development.
- Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.
- Willingness to travel domestically.
- Visual acuity and sufficient dexterity to constantly operate a computer and other office productivity machinery (i.e., a calculator, copy machine, and computer printer) in a stationary position.
- Work on nights or weekends is not typically required, however, interaction on global clinical studies requires flexibility for occasional teleconferences / meetings outside of core working hours.
- The capabilities required for this role are for a proven leader which means the candidate demonstrates the ability to manage delegated aspects of the study with minimal direction, is self-aware and takes initiative to fix and learn from mistakes, demonstrates good judgment in seeking guidance and exercises professionalism.
- Experienced in managing aspects of one or more early development phase (I and II), global, complex, clinical studies and generally experienced in clinical research/development.
- Highly effective verbal (including oral presentations) and written communication skills in English; effectively delivers key messages; aptitude to independently communicate with teams and stakeholders.
- Demonstrates an aptitude to distill information from multiple sources to create meaningful insights and induces collaboration and innovative thinking study-wide.
- Demonstrated experience in at least one therapeutic area.
- Experience with effective vendor management.
- Demonstrates an aptitude for strategic thinking skills; manages risks (including risk identification and mitigation); identifies critical path / critical dependencies.
- Strong customer focus with investigators, functional peers, vendors, country affiliates, etc.
- Excellent planning and organizational skills.
- Ability to build trusting and collaborative relationships that promote innovation, knowledge-sharing and adaptation to change.
- Practices the ability to influence and negotiate to achieve team goals.
- Demonstrates creativity and innovation to support projects.
- Strong technical and analytical skills and ability to manage system data maintenance across multiple systems. Aptitude to interpret outputs from analytical tools to enhance and improve study execution.
- Self-motivated, achievement-driven and exhibits ability to work with minimal guidance.