Senior Manager, Clinical Project Management

Position : Senior Manager, Clinical Project Management

Salary : $175,000 to $178,000 per year

Location : Remote, USA

Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We're proud of the impact we make and just last year, we supported over 780 discovery projects , 1,000+ CMC programmes , and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers . To learn more, visit .

Job Overview :

1) Evaluation and Initiation of the Project.

• Review the project contract with heads of appropriate functional departments and determine project team members as needed.
• At the same time as the contract is awarded, apply for project team member resources from the appropriate Line Manager.
• Conduct team initial meetings; review the contract to develop project implementation and communication plans.
• Ensure that the information entered into the management system is correct and complete.
• Provide or arrange project-related training for team members.
• Prepare and update the master operating plan (SOP).

2) Be responsible for the development of project-related plans and forms.

3) Be responsible for monitoring and controlling the schedule of the entire project to ensure that the trial is carried out according to the plans. At the same time, ensure that the project is completed in accordance with the budget, schedule, and contract specifications.

4) Ensure that all clinical operations and procedures comply with the requirements of the protocol, SOP, ICH-GCP / China GCP, and relevant laws and regulations.

5) Be responsible for the calculation and application of investigational products at the project level and ensure that the packaging and quantity of investigational products meet the requirements of the trial.

6) Be responsible for the planning and conducting of the investigator meeting and ensure that the investigator meeting will achieve the desired results.

7) In collaboration with the Data Manager, the CRFs are reviewed and developed in accordance with the trial protocol. Ensure that the CRFs are available at the trial site prior to FPFV.

8) Regularly hold CD / cross function meetings to assign responsibilities and tasks to team members, monitor the schedule of each project task, and assess the overall status of the project, with particular attention to the following : collection and submission of regulatory documents, trial site initiation status, recruitment status, monitoring visit reports, trial site drug inventory, safety events, and case report forms received.

9) Be responsible for reviewing meeting minutes, internal and external correspondence, and all project-related reports. (Including study site on-site monitoring visit reports and telephone communication reports), follow-up correspondence, travel schedules, travel reports, and project costs.

10) Ensure the timeliness, accuracy, and integrity of the documents in the master file of the trial project and ensure the quality of clinical trial data.

11) Communicate the scope of work, schedules and project objectives, technical information, and customer comments to team members at the project level and l ead any budget and / or scope change orders, if necessary.

12) Maintain appropriate resources for projects and manage the utilization at least monthly to maximize quality and revenue.

What We're Looking For :

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture : You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centred" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits : As part of our commitment to your well-being, we offer a comprehensive benefits package :

How to Apply :

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

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