Position Summary :
- The Clinical Trial Lead (CTL) / Study Lead will establish track and deliver clinical operations milestones
- The CTL / Study Lead will provide direction and leadership to the clinical operations study team and manage daily clinical operations management and execution
- CTL / Study Lead is the single point of accountability for all stages of clinical operations activities from early study design start-up active study and close-out
- Candidates will have extensive prior experience in similar role with proven track records of successful clinical study completion with adherence to timelines budget and milestones
- Candidates will have in-depth knowledge of applicable clinical research guidelines and regulations as well as software tools and systems used in clinical conduct (e.g. CTMS eCRF TMF etc.)
Essential Duties and Responsibilities :
Execute clinical operations deliverables for our clients productsLead clinical activities directing and leading the study team as above in alignment with business goals objectives milestones and timelinesCollaborate with Clinical Affairs management Clinical Program Management Clinical Science Clinical Supply / Logistics Compliance and the various functional groups (R&D Biometrics Medical Affairs) as well as external contacts (study investigators and research coordinators)Identify risks that may impact the overall project plan and initiate contingency plans as appropriateDevelop / Revise and / or provide input in the development of clinical trial related documents including but not limited to :Study protocols training materials case report forms informed consents IRB submissions source documents timelines clinical monitoring plans reference manuals supply listings monitoring tools presentations meeting materials (agenda and minutes)Lead functional strategy discussions study meetings and alignment meetings as neededFunction as a Subject Matter Expert where appropriateWork independently to manage all clinical tasks and deliverables with limited oversightCreate and implement training programs and process improvementsAssists management with departmental audits of clinical studies and proceduresRequired Knowledge / Skills / Abilities :
Extensive experience in all aspects of clinical trial design and executiono Minimum of 8-12 years related experience in a medical device pharmaceutical IVD and / or CRO
o Minimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study team
Thorough understanding of the processes associated with study preparation study management knowledge of Good Clinical Practices (GCPs) monitoring clinical and regulatory operationsTechnical expert in the various aspects of the clinical evaluation processHistory of significant contribution to the success of planning and executing clinical strategies in support of product clearanceStrong interpersonal and communication skillsExcellent organizational skills and attention to detailAbility to manage multiple prioritiesPreferred Qualifications :
Diabetes experience desirable but not mandatoryExperience in the medical device industry Pharma BioTech and / or CROExperience in continuous glucose monitoring (CGM) is a plusProfessional certification (e.g. CCRA (ACRP) CCRP (SoCRA) PMP ACRP RAPS)Travel Required :
The job may require travelling up to 25%-30% of the time as needed; some international travel may be requiredCandidate Location : Remotely within United States or local to San Diego CaliforniaFunctional / Business Knowledge
Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.Scope
Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods techniques and evaluation criteria for obtaining results.Judgement
Exercises good judgment in selecting methods and techniques for obtaining solutions.Normally receives little instruction on day-to-day work general instructions on new assignments.Experience and Education
Bachelors Masters or PhD degree in a technical / scientific discipline and a minimum of 8-12 years related experience in a medical device pharmaceutical IVD and / or CROMinimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study teamKey Skills
CSS,Cloud Computing,Health Education,Actuary,Building Electrician
Employment Type : Contract
Experience : years
Vacancy : 1