Site Start up EUCTR II/ Initiation Clinical Research Associate II

Reposted 13 Hours Ago
Be an Early Applicant
Hyderabad, Telangana, IND
In-Office
Mid level
Pharmaceutical
The Role
Plan and submit complex EUCTR submissions for phase II/III multi-country trials; lead site start-up activities, coordinate cross-functional teams and vendors, apply ICH/GCP, EUCTR and IVDR requirements, use CTMS/TMF and MS Project to track progress, and support study start-up operational strategy.
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.

Site Start Up EUCTR II

  • Responsible for planning and submitting the complex EUCTR submission i.e. large phase II and III trials with multiple countries and sites.

Job Requirements: In addition to the core duties outlined, the following qualifications are required for the Site Start Up EUCTR II

  • Interpersonal & leadership skills
  • Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
  • A data driven approach to planning, executing, and problem solving
  • Effective communication skills via verbal, written and presentation abilities
  • Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
  • Ability to build productive study teams collaborations
  • Vendor management experience
  • Basic proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel
  • Experience in the clinical drug development process, including study start-up
  • Knowledge of ICH/GCP, EUCTR and IVDR regulatory guidelines
  • Basic project management skills, cross-functional team interaction and organizational skills
  • May require up to 25% travel
  • Bachelor’s degree and 3-4 years of relevant experience.

Skills Required

  • Interpersonal and leadership skills
  • Ability to understand and implement operational strategic direction for clinical studies
  • Data driven approach to planning, executing, and problem solving
  • Effective verbal, written and presentation communication skills
  • Proactive and self-disciplined with strong time management and prioritization
  • Ability to build productive study team collaborations
  • Vendor management experience
  • Basic proficiency in trial management systems (CTMS, TMF)
  • Proficiency in MS applications including Project, PowerPoint, Word, Excel
  • Experience in the clinical drug development process, including study start-up
  • Knowledge of ICH/GCP, EUCTR and IVDR regulatory guidelines
  • Basic project management skills and cross-functional team interaction
  • Willingness to travel up to 25%
  • Bachelor's degree and 3-4 years of relevant experience

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.

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The Company
HQ: Raleigh, NC
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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