The Genentech Research and Early Development (gRED) Global Clinical Trial Leader (CTL) 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 CTL 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 CTL enables the efficient delivery of global clinical studies, under the leadership of the Sr. CTL.
The CTL is a developing leadership role that will increasingly demonstrate the ability to work independently, problem-solve, effectively collaborate, and innovate.
Role & Key Responsibilities:
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.
Partners closely with Clinical Science in designing global clinical trial protocols and 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.
Serves as subject matter expert for mandatory business initiatives and/or functional initiatives.
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 developing 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.
Consistently supports change in an effort to continue to develop gRED’s dynamic organization.
Demonstrates creativity and innovation to support projects and initiatives.
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.
Education / Qualification:
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.
Other (e.g. Travel):
Willingness to travel domestically and internationally, and work across cultures.!
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.
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