Country Operations Manager - FSP

Posted 5 Days Ago
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Hiring Remotely in Brazil
Remote
Senior level
Pharmaceutical
The Role
Lead country-level setup, execution and delivery of clinical trials in compliance with GCP-ICH and local regulations. Oversee CRO/vendor management, budget creation and oversight, site feasibility and selection, patient recruitment planning, training, risk mitigation, and team leadership. May perform monitoring visits as needed.
Summary Generated by Built In

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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Skills Required

  • Minimum of 5 years of relevant clinical trial management experience
  • Experience managing outsourced trials or CRO management
  • Vendor management experience
  • Knowledge of GCP-ICH, local/global regulations, and clinical SOPs
  • Excellent leadership, communication, and organizational skills; ability to multi-task and work independently
  • M.S/M.A/Ph.D or B.A/B.S or nursing degree
  • Experience managing oncology studies
  • Must reside in Germany (fully remote, Germany-based candidates only)

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

Parexel Insights

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The Company
HQ: Durham, North Carolina
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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