Clinical Project Management

Location

Piscataway, NJ | United States

Job description

Join our dynamic team at Pharmaron where innovation meets excellence in clinical research.

As we continue to grow, we are seeking to add a skilled Clinical Trial Project Manager to join our team and play a pivotal role in supporting critical projects that shape the future of medicine.

This role is remote based in the USA.

What you will do:

The Clinical Project Manager is a pivotal role responsible for overseeing the direction, implementation, coordination, and execution of global-scale clinical projects.

In addition:

• Collaborate with heads of relevant functional departments to review project contracts and identify necessary project team members.
• Apply for project team member resources from the appropriate Line Manager upon contract award.
• Conduct initial team meetings, developing project implementation and communication plans based on contract review.
• Verify and ensure the accuracy and completeness of information entered into the management system.
• Provide or organize project-related training for team members.
• Prepare and update the master operating plan (SOP).
• Develop project-related plans and trial-related forms, including project management, clinical monitoring, risk management, communication, recruitment, document management, and quality management plans.
• Monitor and control the project schedule, ensuring adherence to plans, budget, and contract specifications.
• Ensure compliance with protocol, SOP, ICH-GCP/China GCP, and relevant laws and regulations in all clinical operations and procedures.
• Timely report safety events and related deviations according to protocol and regulatory requirements.
• Calculate and apply investigational products at the project level, ensuring compliance with trial requirements.
• Plan and conduct investigator meetings, ensuring desired outcomes.
• Collaborate with the Data Manager to review and develop Case Report Forms (CRFs) in accordance with the trial protocol.
• Hold regular team meetings to assign responsibilities, monitor project task schedules, and assess overall project status.
• Review meeting minutes, internal and external correspondence, project-related reports, and ensure timely submission of project briefings to the Sponsor.
• Ensure the timeliness, accuracy, and integrity of documents in the trial project's master file.
• Conduct collaborative monitoring of trial sites, identifying and guiding resolution of site problems.
• Maintain project resources, managing utilization at least monthly to optimize quality and revenue

What We are Looking for:

Your proficiency in Clinical Trial settings and as a Clinical Project Manager, combined with your comprehensive experience overseeing the entire clinical project lifecycle from initiation to closure, will be crucial skills that will contribute to success in this position.

Qualifications and Experience:

• Minimum of 12 years of clinical trial-related work with 5 years or more in a Clinical trial PM role preferably at a CRO, Biotech or Pharma company
• Proficiency in ICH-GCP, Chinese GCP, and relevant laws and regulations.
• Experience of phases I/II/III/IV (full lifecycle) as a Project manager is highly desirable.
• Degree in Medicine, Pharmacy, Life Science, or related specialities preferred.
• Excellent English language skills both verbal and written is essential. Chinese speaking is also desirable.

Why Pharmaron?

Pharmaron is a premier contract research organization that offers a broad spectrum of R&D and manufacturing service capabilities throughout the entire drug discovery, preclinical, clinical development and commercialization process. With a workforce of over 20,000 professionals and operations spanning the U.S., U.K and China.

Our Culture: You'll 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 Centered" 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.

Your benefit package: As part of our commitment to your well-being, we offer a comprehensive benefits package, including medical, dental, and vision insurance with significant employer contributions. Planning for your future is made easier with our 401k plan and employer match. Plus, you'll have access to an Employee Assistance Program to support you in work and life.

EEO/AA Statement:

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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