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

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.

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

reputed company FSP is currently reputed company 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 reputed company budget and timelines.
• reputed company 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, reputed company 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 reputed company

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

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

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

reputed company 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