Job Description: Clinical Trial Support Manager

Employment Type: Full time Work Schedule: Other Environmental Conditions: Office

Position Overview

When you join the team at Thermo Fisher Scientific, you will do meaningful work that makes a positive impact on a global scale. Join 130,000 colleagues who bring our mission to life every single day to enable our customers to make the world healthier, cleaner, and safer!

Our global Clinical Research team, which powers our PPD® clinical research portfolio, is our leading global contract research organization (CRO). We provide comprehensive, integrated drug development, laboratory, and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic, and government organizations.

This role is dedicated to our [post approval or clinical trial support team], a part of our global Medical Communications business. We are redefining medical communications. We go beyond expertise, strategic thinking, and innovative technology and seize every opportunity to create connections and lasting relationships with patients, caregivers, and healthcare providers (HCPs).

We deliver robust industry expertise and support for medical information and clinical trial contact centers. We believe in a people-centric approach that infuses a caring attitude at every touch point and considers the needs of each individual.

Position Summary

Manages the day-to-day operations of one or more projects and directs, mentors, and supports operations managers and other members of their project teams. Ensures that services are provided in accordance with client and PPD Medical Communications' policies and procedures and contractual agreements. Serves as the primary liaison with the client and ensures project report summaries, budget, audit results, staffing decisions, and other critical issues are managed appropriately. Ensures execution of deliverables meet time, quality, and cost expectations.

Responsibilities

• Ensures timely and effective completion of deliverables such as scope of work, contractual matters, changes in staffing levels, and budget negotiation by being the main client contact.
• Troubleshoots database issues, phone routing, or other issues affecting different departments at PPD, vendors, or client departments.
• Retains project knowledge; coordinates and establishes new project operations, and monitors project processes (QA, compliance, SOPs, regulatory) to elevate quality and client dedication.
• Reads protocols and translates them into project execution that aligns with Med Comm policies and procedures.
• Manages staff responsibilities including performance management, salary administration, hiring, employee relations, employee engagement, conflict resolution, and employee development.
• Liaises with cross-functional leaders to drive deliverables.
• Ensures quality objectives are met and develops and maintains project SOPs.
• Develops, reviews, and/or follows corporate SOPs, including SOPs, protocols, GCPs, and regulatory authority compliance.
• Ensures maintenance of profitability through management of billable hours.
• Ensures client budgetary goals are met.
• Ensures accuracy and timeliness of client invoice amounts and communicates required changes to Medical Communications finance.
• Participates in capabilities presentations to help secure new business and alerts the Director and Business Development team to new business opportunities with existing clients.
• Reviews and provides operational input on proposals, contracts, and/or renewals associated with existing clients.
• Participates in the development of processes and strategies designed to assist in meeting the above-stated goals on a division-wide basis.
• Fosters a culture of immediate action and proactive addressing of critical issues.

How Will You Get Here?

• Experience with Clinical Trial (Phase 1-4) preferred.
• Previous experience in health care or pharmaceutical industry that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years).
• Proven leadership skills to include: