Senior Clinical Research Associate - Sponsor Dedicated

Reposted 14 Hours Ago
Be an Early Applicant
Hiring Remotely in Berlin, DEU
In-Office or Remote
Senior level
Pharmaceutical
The Role
Manage clinical trial sites ensuring compliance with regulations, monitor adverse events, and facilitate communication across study teams. Requires extensive clinical research experience.
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 FSP is hiring for two experienced CRA's at either the CRA II or Senior CRA level to join one of a large Sponsor’s in the EU.  

This role is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution

Some specifics about this advertised role

  • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.

  • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met.

  • Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.

  • Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution.

  • Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable

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 in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

  • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations

  • Monitoring Experience: Minimum 3.5 years relevant experience in clinical research site monitoring (preferably in Oncology)

  • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases

Skills Required

  • Bachelor's degree in life sciences or equivalent
  • Extensive knowledge of clinical trial methodologies and regulations
  • Minimum 3.5 years of clinical research site monitoring experience
  • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases

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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