Clinical Trial Lead (CTL)/Study Lead

Pride Health is seeking a Clinical Trial Lead/Study Lead for a manufacturer of Continuous Glucose Monitoring systems in San Diego, CA.

Job Title: Clinical Trial Lead (CTL)/Study Lead

Location: San Diego, CA 92121

Job Type: Contract

Length: 3-Months

Hours: 40 hours/week

Travel: up to 25%-30% of the time as needed; some international travel may be required

Pay Rate: $65.00 - $72.65 per hour

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 Company products
• 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

Requirements:

• Bachelor’s, Master’s, or PhD degree in a technical / scientific discipline
• 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
• Extensive experience in all aspects of clinical trial design and execution
• 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

Preferences:

• 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

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.

Benefits that Pride Health offers:

Pride Health offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

Apply Today! If you are interested in the position, please email your resume to rob.vanriet@pride-health.com for immediate consideration.