Offer summary

Qualifications:

Minimum of 2 years' experience in clinical trial management with a focus on study startup and lifecycle management., Experience in the CRO, pharma, or biotech industry is essential, with a preference for candidates with vendor management experience., Comprehensive knowledge of IRB/EC submissions and experience in reviewing CRA MVRs is required., A degree in a science-related field is preferred. .

Key responsabilities:

Oversee study-specific country-level activities from startup through to study close for studies of limited complexity.

Coordinate and manage tasks as part of a larger study management team, ensuring compliance with regulatory requirements.

Engage in vendor management and collaborate with various stakeholders to facilitate study operations.

Work within a matrix management environment to ensure effective communication and project execution.

Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is currently hiring for a Study Operations Manager, home-based.
Permanent, full-time.

Single sponsor dedicated to a worldwide biopharmaceutical company that relentlessly seeks breakthroughs to improve patients’ lives. Their daily innovation contributes to a healthier global community. This is where today’s visionaries, solution-seekers, and trailblazers converge to shape tomorrow’s groundbreaking solutions. Together, we have the power to revolutionize patients’ well-being. Every choice we make and every step we take is guided by our unwavering focus on patients, fostering an environment where innovation thrives.

The Study Operations Manager I (SOM I) have responsibilities for study specific country-level activities from study startup through conduct and study close on studies of limited complexity.

Candidates with the following experience will be considered:
Start Up Project Managers, Country Trials Managers, Site Activation Managers, Clinical Trial Managers with country/region oversight experience.

Required:
•   Good recent study startup experience and 2 + years’ experience in leading the full lifecycle of clinical trial stages in the local country.
•   CRO, pharma and/or biotech industry experience; not only academic center (SMO) experience.
•   IRB/EC submissions experience.
•   Vendor management experience
•   Experience in reviewing CRA MVRs.
•   Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team.
•   Experience working in a matrix management environment.
•   Education: degree or higher - preferably science-related.

We offer exceptional financial rewards, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.

Apply today!

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