Country Operations Manager - 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 are actively pre recruiting for a new Country Operations Manager in Brazil.

In this role you will be accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the local level. You’ll contribute to delivery of the pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites. You may be required to perform monitoring visits if the need arises.

 At the same time you’ll provide leadership and direction to the wider trial team and you will be accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators.

This will be a fully remote home-based position, only candidates that live in Germany can be considered at this time.

Some specifics about this advertised role

• Verify the trial is conducted in compliance with GCP-ICH, local/global regulations, application SOPs and according to the trial protocol by overseeing CRO and internal team activities.
• Creation, management, and review of the trial budget to verify appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.
• Appropriate trial-specific training of internal and external partners is performed in line with trial training plan.
• Accurate planning and co-ordination of operational feasibility of trial timelines and oversight of trial preparation to verify trial team members are aligned and on track
• Verifies and provides input into the country and site level feasibility and commitment. Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions.
• Development and implementation of country level engagement plans, recruitment planning and risk mitigation.
• Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value.
• Maintains oversights during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring /mitigation. In collaboration with other functions, verifies budget oversight, including support of regular clinical quality monitoring, and safety reporting.

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

• Minimum of 5 years of relevant clinical trial management experience.
• Experience of managing oncology studies is preferred.
• Experience managing outsourced trials or CRO Management
• Vendor Management experience
• Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative.
• M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential.

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