Early Phase Clinical Project Manager

Syneos Health; Bloemfontein; On-site; USD 60 000 - 100 000; Full time

Job summary

An established industry player is seeking a dedicated Early Phase Clinical Project Manager to lead interdisciplinary clinical research studies. This role is vital in ensuring compliance with GCP and managing project timelines and budgets. You will collaborate with passionate professionals to drive success and foster strong client relationships. With a focus on career growth and a supportive culture, this position offers a unique opportunity to make a significant impact in the biopharmaceutical field while working in a dynamic and innovative environment. If you are driven by results and eager to contribute to life-changing therapies, this role is for you.

Qualifications

• Bachelor's degree in life sciences or equivalent required.
• Experience in CRO and knowledge of GCP/ICH guidelines preferred.

Responsibilities

• Manage interdisciplinary clinical research studies ensuring compliance with GCP.
• Serve as the primary liaison between company and customer for project delivery.
• Lead project teams to ensure quality, timelines, and budget management.

Skills

Organizational Skills

Time Management

Communication Skills

Interpersonal Skills

Knowledge of GCP/ICH Guidelines

Problem Solving

Education

Bachelor's Degree in Life Sciences

Equivalent in Medicine, Pharmacy, or Nursing

Job description

Description

Early Phase Clinical Project Manager

Sponsor Dedicated

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model places the customer and patient at the center of our work. We continuously seek to simplify and streamline our processes to make Syneos Health easier to work with and for.

Whether in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers, innovating as a team to help our clients achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people through career growth, supportive management, training, peer recognition, and total rewards.
• We foster a Total Self culture where you can be authentic. We are committed to taking care of our people and creating a sense of belonging through diversity of thought, background, and culture.

Job Responsibilities

Project Leadership and Delivery:

• Manage interdisciplinary clinical research studies, ensuring compliance with GCP, SOPs, and regulations.
• Serve as the primary liaison between the company and the customer to ensure timely study launch, conduct, and closeout.
• Lead project teams to ensure quality, timelines, and budget management.
• Be accountable for the financial performance of each project.
• Coordinate activities and deliverables of study partners, proactively managing issues.
• Ensure studies comply with GCP, SOPs, and regulatory requirements.
• Oversee all project deliverables for assigned projects.

Documentation And Reporting

• Ensure quality and completeness of TMF for assigned projects.
• Maintain study information in databases and systems.
• Manage inspection readiness for study conduct.
• Develop and implement project plans.
• Present at internal and external meetings.
• Prepare management and client reports.
• Develop contingency plans and risk mitigation strategies.

Business Development

• Build strong relationships with clients to generate new or additional business.
• Participate in bid defense meetings as a potential project manager.

Management

• Line manage project management team members and clinical staff as required.

Qualifications

What we’re looking for

• Bachelor’s degree or equivalent in life sciences, medicine, pharmacy, or nursing.
• Experience in CRO and relevant therapeutic areas preferred, with strong knowledge of GCP/ICH guidelines and regulations.
• Strong organizational and time management skills.
• Therapeutic area expertise.
• Ability to adopt new technologies.
• Excellent communication and interpersonal skills, both written and spoken.
• Willingness to travel (~25%).
• Experience managing early phase global studies.

Get to know Syneos Health

In the past 5 years, we've worked with 94% of FDA-approved drugs, 95% of EMA-approved products, and over 200 studies across 73,000 sites and 675,000+ patients. No matter your role, you'll challenge the status quo in a dynamic environment. Learn more about Syneos Health.

Additional Information

Tasks and responsibilities are not exhaustive. The company may assign additional duties at its discretion. Equivalent experience or education will be considered. This description does not constitute a contract. We comply with applicable legislation, including the EU Equality Directive and the Americans with Disabilities Act, providing accommodations when necessary.