Actalent • Boston, MA 02133
Job #2686238495
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.)
Execute clinical operations deliverables
Lead clinical activities, directing, and leading the study team as above in alignment with business goals, objectives, milestones, and timelines,
Collaborate 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 appropriate
Develop/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 needed
Function as a Subject Matter Expert where appropriate
Work independently to manage all clinical tasks and deliverables with limited oversight
Create and implement training programs and process improvements
Assists management with departmental audits of clinical studies and procedures
Required Knowledge/Skills/Abilities:
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 operations
Technical expert in the various aspects of the clinical evaluation process
History of significant contribution to the success of planning and executing clinical strategies in support of product clearance
Strong interpersonal and communication skills
Excellent organizational skills and attention to detail
Ability to manage multiple priorities
Diabetes experience desirable, but not mandatory
Experience in the medical device industry, Pharma, BioTech and/or CRO
Experience in continuous glucose monitoring (CGM) is a plus
Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS)
The job may require travelling up to 25%-30% of the time as needed; some international travel may be required
Candidate Location: Remotely within United States or local to San Diego, California
Functional/Business Knowledge
Scope
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.
clinical research, clinical trial
Additional Skills & Qualifications:
Bachelor's, Master's, 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 CRO
Minimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study team
Expert Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ~~~ (~~~) for other accommodation options.
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