Clinical Trial Leader
One DNA Way South San Francisco, CA 94080 | Contract
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- 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.
- Contributes to global study site selection & management: Conducts global protocol, country, and site feasibility assessments. Assists with all activities related to global site selection, contracting, set-up and maintenance. Partners with Site Contracts on development of site budget template and budget negotiations.
- Contributes to the development and active management of study-specific patient recruitment strategies through participation in enrollment planning workshops. Proactively identifies risks and develops risk mitigation strategies to ensure operational effectiveness.
- Contributes to the efforts and overall success of the wider gRED Clinical Operations team: Collaborates effectively and participates in the CTL Forum and other departmental meetings. Identifies and synthesizes best practices and process improvements and shares outputs with peers.
- 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.
- The capabilities required for this role are for a proven leader with 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.
- 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.
- Bachelor's degree or equivalent required (scientific or healthcare discipline preferred).
- 3+ years of study management experience in clinical and drug development.
- Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.
- Other (e.g. Travel): 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.