Clinical Trial Lead

Collaborates with various departments on the design documentation testing and implementation of clinical data studies. Develops systems for organizing data to analyze identify and report trends. Analyzes the interrelationships of data and defines logical aspects of data sets. Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports.

Summary:

Able to work under minimal supervision to implement and monitor clinical studies at participating study sites according to FDA's Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and ICH Guidelines. Assists Clinical Affairs management to plan and execute the design and conduct. Assists with overall study planning and ensuring that all site visits, monitoring, data collection, reports, and ancillary requirements are appropriately assigned and executed to meet company deadlines, quality expectations, and priorities. Learn to act as department representative/clinical project leader on project teams. Works collaboratively with company's Biometrics, R&D and Regulatory Affairs groups to compile study results, reports and/or tracking various study documentation.

Essential Duties and Responsibilities:

• Partner with Clinical Affairs management to develop and execute clinical studies.

• Communicate progress updates to Clinical Affairs management and the various functional groups (R&D, Biostats, Clinical Operations).

• Write/reviews protocols, and study reports in consultation of CRA personnel and/or study manager.

• Develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under direct supervision of study lead and/or study manager.

• Maintain thorough understanding of clinical regulations and standards (including changing regulations).

• Create and implement regular process improvements.

• Act as a study and/or site lead for multiple sites/projects simultaneously.

• Clearly demonstrate understanding of clinical study management/prioritization.

• Conduct site initiation, monitoring, and close-out visits

• Complete study monitoring visits.

• Assist with documenting initial and re-qualification of new clinical sites

• Assist with developing monitoring plan and conventions for studies.

• Act as primary contact for clinical sites.

• Act as lead coordinator or monitor for Sponsor-Investigator studies.

• Work on projects and routinely creates, suggests, and/or implements regular process improvements.

• Work independently to manage all clinical tasks and deliverables to meet clinical timeline

• Provide training to study staff and subjects at clinical sites.

• Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders.

• Responsible for identifying and escalating major protocol deviations

• May assist with assessing trends for safety and protocol deviations and communicating this to study team and study manager

• Maintain organization, preparation and ordering of supplies and equipment required for clinical studies.

• Process timely shipping of clinical study supplies and equipment.

• Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures.

• Complete testing of electronic data capturing systems.

• Quality control SME for study-related documents and be accountable for their correct distribution.

• Initiate distribution of all regulatory documents and maintain for assigned clinical trials.

• Provide support to CRA personnel for preparing documentation, reports, and presentations.

• Coordinate study-related meetings, as needed.

• Perform scribe function during clinical meetings and produce meeting minutes for management review.

• Assists management with departmental audits of clinical studies and procedures.

• Coordinate Sponsor-Investigator studies and complete all study-related responsibilities.

• Maintain tracking mechanism for regulatory documents for any regulatory submission (FDA or other regulatory body).

• Prepare of key documents for trial site submission to IRBs.

• Assist in the creation and maintenance of tracking mechanisms for all study-related documents, activities, and projects through all phases of the study.

• Draft clinicaltrials.gov submissions.

• This position assumes and performs other duties as assigned.

• Complete tasks under minimal or no direct supervision.

Experience and Education Requirements:

• Bachelor's (BA or BS) degree in a STEM discipline, and at least 8 years of related experience.

or Master's degree in a STEM discipline, and 5 years of related experience.

• Current GCP (Good Clinical Practice) Training.

• Clinical Trial Management System (CTMS) experience.

• Manage multiple, diversified tasks concurrently and to prioritize projects and tasks effectively.

• Monitoring clinical studies experience.

Preferred Qualifications:

• Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS).

• Study coordinator experience.

Travel Required:

• 25-50%.

• Local to San Diego, California or willing to relocate OR may work remotely elsewhere, with approval.

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 for other accommodation options.