Associate Manager, Clinical Operations - FSP

Fortrea•Durham, NC

2d•Remote

About The Position

Fortrea's FSP team is hiring an Associate Manager, Clin Ops! This is a remote-based position in the US. The role involves managing and developing a clinical operations team of Clinical Research Associates, contributing to and overseeing resource planning and assignments. The Associate Manager will provide monitoring oversight to ensure all activities are conducted to the highest quality standards and in accordance with ICH/GCP guidelines.

Requirements

University/college degree - life sciences preferred or certification in a related allied health profession from an approximately accredited institution (e.g., nursing certification, medical or laboratory technology). Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Minimum of two (2) years supervisory experience in a health care or clinical research setting (in lieu of required education background).
Minimum of six (6) years relevant clinical research experience in a pharmaceutical company/CRO (in lieu of required education background).
Relevant clinical research experience in a pharmaceutical company or CRO: Individual is proficient with on-site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits).
Minimum of four (4) years relevant clinical research experience in pharmaceutical company/CRO.
Thorough knowledge of drug development process.
Thorough knowledge of relevant SOPs, ICH, and GCP guidelines.
Some experience as a Line Manager or Project Manager preferred.
Demonstrated ability to lead by example and to encourage team members to seek solutions.
Proven interpersonal skills.
Demonstrated ability to successfully participate as a member of a project team.
Demonstrated ability to successfully manage multiple competing priorities.
Excellent planning and organizational skills.
Excellent oral, written and presentation skills.

Nice To Haves

Master’s or other advance degree.
Phase I monitoring experience preferred.

Responsibilities

Responsible for detailed performance review and management of assigned direct reports including Annual Performance Management and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and "Shoves and Tugs".
Responsible for appropriate management and resolution of performance issues.
Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables.
Engage in resource management activities for direct reports.
Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports.
Measure performance indicators for assigned staff within Clinical Operations.
Escalate potential individual training needs and assist in the conduct of training and development efforts, regionally.
Effectively communicate management strategies, policies, and procedures in conjunction with leadership teams.
Develop and maintain effective relationships with management team to manage Clinical Operations staff in a matrix environment.
Conduct, report and follow up on Quality Control Visits (CQC).
Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.
Provide oversight on monitoring activities associated with the site-level evaluation, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trial sites.
All other duties as needed or assigned.