Clinical Operations Manager

Description:

Remote Clinical Operations Manager with 30% travel

• Responsible for single molecule
• 5 years' experience- CRA Management and Oversight

o Will be managing upwards of 8-10 CRAs. Will be involved in development and training of CRAs. They will run performance evaluations.

o Line Manager for CRAs. Responsible for site assignments.

• Co monitor when needed

o Must come from a monitoring background

• SOP development

• Review trip reports

• Coordinate with Project Manager

• Meet with sites- including KOLs and Investigators.

• Systems experience- IRT systems, EDC systems

RESPONSIBILITIES:

• Lead and manage the clinical monitoring network in the United States.

• Lead clinical operations in the United States in support of the clinical research trials.

• Train and develop clinical research associates (CRAs).

• Coordinate with the Clinical Project Managers in execution of monitoring and site management

deliverables.

• Ensure overall clinical operations study timelines are maintained.

• Line management of CRAs.

• Assess CRA performs and address issues promptly.

• Assess and review investigational site metrics in collaboration with Clinical Project Manager(s) and

Head of Clinical Operations, USA.

• Serve as primary reviewer of monitoring visit trip reports.

• Maintain and track investigational site monitoring metrics.

• Function as a primary contact and partner for the Clinical Operations team.

• Develop and foster relationships with key opinion leaders and investigators.

• Ensure all clinical trial activities are carried out in compliance with Good Clinical Practices and

applicable FDA regulations.

• Establish and oversee day-to-day clinical monitoring performance, ensuring compliance with policies,

procedures, and standard.

• Provide input and feedback on the clinical strategic approach and the impact on the overall clinical

development plan.

• Collaborate with the Clinical Project team in review of clinical trial protocols.

• Develop clinical monitoring plans and review additional study plans for the clinical trial, including but not

limited to: Monitoring Plan, Safety Reporting Plan, Communication Plan, Risk Management Plan.

• Learn medical and scientific details of the study indications.

• Collaborate with internal partners and vendors for the management of clinical supply (investigational

product) logistics, accountability, and destruction, drawing support from the monitoring team.

• Perform additional duties assigned by line manager

EDUCATION & EXPERIENCE:

• Bachelor's Degree in Life Sciences.

• Seven years of previous experience in the Pharmaceutical Industry/Contract Research Organization.

• Four years line management of CRAs. Leadership role as a Trial Manager, Clinical Trial Lead, or

comparable position may be considered.

• Five years of monitoring experience.

• Study plan writing experience.

• Expertise in Clinical Trial Management Systems.

• Experience with trial master file maintenance, auditing, and reconciliation, particularly on a site level.

• Experience working in a multicultural environment with sensitivity to cultural distinctions

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.