Global Trial Manager/Study Operations Manager - 0.8 FTE - Remote - FSP

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 recruiting for an experience Global Trial Manager or project manager who has experience managing outsourced trials, who can confidently manage two CRO partners.

This role is available as a 0.8FTE role with flexibility on hours/days worked

Some specifics about this advertised role

• Ensure that clinical trial/study is managed and executed in compliance with the QMS, regulations and ICH GCP and within budget and timelines.
• Lead and manage the clinical trial team, providing guidance and support to team members in regards to their area of expertise and responsibility. Accordingly, the GTM/SOM is expected to schedule, coordinate and follow up with team meetings and actions.
• The SOM is expected to navigate and manage the operational complexity of studies i.e. connecting and planning with the right internal and/or external stakeholders depending on the study complexity (number of countries and sites in-scope, number of vendors, etc.) This effort will vary depending on the type of model used for each study (ranging from outsourced to in-housed activities)
• Establish strong relationships with investigators, investigational site staff and other relevant external stakeholders, when required. Additionally, work closely with Clinical Site Manager(s) or relevant site-facing teams.
• Participation in clinical study audits and inspections, ensuring readiness in collaboration with Quality Assurance

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing
• Prior experience managing registration trials is preferred
• Prior experience managing CRO vendors is essential
• Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization.
• Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety.
• Ability to prioritize and manage multiple tasks simultaneously.

Originally posted on Himalayas