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Description:

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

• 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:

• Extensive experience in all aspects of clinical trial design and execution o 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 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

Preferred Qualifications:

• 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)

Travel Required:

• 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

• 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.

Skills:

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

Experience Level:

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.