This job opportunity is with a clinical stage bio-pharmaceutical company that is focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias. They are looking to add a Clinical Operations Manager to their team! The team is actively interviewing candidates and the organization has great culture!

　　Description:

　　• 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.

　　• 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

　　Additional Skills & Qualifications:

　　5 years’ experience- CRA Management and Oversight

　　SOP development

　　Review trip reports

　　Coordinate with Project Manager

　　Will be managing upwards of 8-10 CRAs

　　Systems experience- IRT systems, EDC systems

　　Strong understanding and training of Good Documentation Practice

　　Strong knowledge of applicable FDA regulations and guidelines

　　Must be well-organized.

　　Must have excellent verbal and written skills.

　　Some measure of flexibility will be necessary. Due to the international framework of the organization, there will be instances when meetings are scheduled during non-traditional hours.

　　The ideal candidate must be able to work independently but consistently.

　　Productive personal interactions are critical to this role. Must have good inter-relationship skills.

　　Education & Experience:

　　Bachelor's Degree required

　　6+ years of previous experience in the Pharmaceutical Industry/Contract Research Organization.

　　Minimum of 5+ years of CRA Management and Oversight experience

　　Experience with protocol management

　　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

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.