Clinical Trial Leader III
1 DNA Way South San Francisco, CA 94080 US
The Global Clinical Trial Leader (CTL) is accountable for the execution and delivery of early development global clinical trials under the leadership of the Sr. CTL. The CTL will actively contribute to the Protocol Execution Team (PET), is experienced at managing vendors, developing risk mitigation strategies and study plans. The CTL champions and supports change related to their study assignments and department goals/objectives. These complex programs focus on the rapid development of new molecular entities with limited or no clinical data, and as such, require implementation of novel and highly flexible global operational strategies.
Role & Key Responsibilities: May include, but not limited to:
- Provides operational expertise to one or more global cross-functional Protocol Execution Team(s) (PETs) through all study stages (start-up, conduct, close-out)
- Creates a positive work environment by encouraging mutual respect, instills innovation and accountability on a functional and project level, both locally and globally to implement and deliver the study.
- Participates in developing, driving and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as vendor specifications, drug supply forecasting, monitoring and communication plans, quality of trial master files and quality of data in systems including CTMS.
- Collaborates with and influences cross-functional team members to solicit input on study plans and coordinates execution of effective investigator meetings.
- Participates in selection of vendors in collaboration with the PETL and oversees delegated outsourced activities to ensure CRO and vendors deliver against contracted scope of work.
- Provides input to the study budget and manages assigned vendor budget(s).
- Through strategic and critical thinking, contributes to managing timelines and critical study activities, identifies issues and proposes potential resolutions.
- Contributes to the identification, assessment and selection of countries and sites
- Contribute to the development of clinical trial protocols/informed consents and provides strategic operational input on protocol feasibility.
- Demonstrates a patient and site-centric mindset in all interactions and through the implementation of study activities.
- Contributes to the efforts and overall success of the wider Clinical Operations team: Partners with colleagues to develop process improvements and establish best practices to enhance the execution of clinical trials across the organization
- May serve as subject matter expert and serve as the single point of contact for functional initiatives.
- Seeks opportunities to coach, mentor and support developing staff, willingly shares expertise and knowledge with peers.
Experience, Skills, Behaviors, Knowledge:
- Recognized as experts in clinical trial management with thorough understanding of execution of clinical trials.
- Is self-aware, exercises good judgement in seeking guidance, proactively addresses issues, exercises professionalism.
- Experienced at managing delegated aspects of one or more early development phases (I and II), global, complex, clinical studies and is generally experienced in clinical research/development.
- Experienced with effectively managing a variety of vendors.
- Effectively communicates and delivers key messages; independently communicates with teams and stakeholders.
- Ability to influence and negotiate to achieve team goals.
- Demonstrates the ability to creatively solve problems including welcoming diversity of thought to make decisions.
- Demonstrates an aptitude for thinking strategically and critically and distilling quantitative and qualitative data to make decisions.
- Experienced at identifying and mitigating risk. Strong customer focus with investigators, functional peers, vendors, country affiliates,etc. with patient being the ultimate customer
- Is flexible, adaptive and successfully navigates self and team through ambiguity, is proactive and solution- focused.
- Consistently champions and supports change to positively impact the business and its customers.
- A developing leader who is curious with a growth mindset and willingness to continuously learn.
Minimum Education / Qualification:
- Bachelors degree or equivalent required (scientific or healthcare discipline preferred).
- 4+ years of study management experience desired
- Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.
- Some travel may be required
Pay Rate Range: $80-120/hr. Salary will be commensurate with experience.
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