Site Activation Partner/Study Start Up Specialist - FSP

Posted 19 Days Ago
Be an Early Applicant
4 Locations
Remote
Junior
Pharmaceutical
The Role
Lead and coordinate clinical trial site activation and operational activities from start-up through close-out. Manage Investigator Initiation Packages, essential documents, regulatory and ethics submissions, site issues, compliance tracking systems, and collaboration with regulatory and supporting teams. Ensure activities meet study timelines, applicable laws, Good Clinical Practice, sponsor standards, and local requirements.
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.

The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards. Other duties to include but not limited to: 

  • Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation   

  • Provide support to resolve issues or concerns and timely escalation of Site issues where applicable 

  • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities 

  • Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required 

  • Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines 

  • Identify and resolve investigator site issues 

Experience required for this role: 

  • School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred 

  • Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation.  

  • Experience working in the pharmaceutical industry/or CRO is an asset 

  • Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations 

  • Must be fluent in Local language and in English. Multi-language capability is an asset 

#LI-LO1

Skills Required

  • School diploma or certificate, or equivalent combination of education, training, and experience
  • Minimum 2 years of relevant experience in a clinical trials environment and clinical site activation
  • Knowledge of clinical trial methodologies
  • Knowledge of ICH/GCP requirements
  • Knowledge of FDA regulations
  • Knowledge of global and local country regulations
  • Fluency in the local language and English
  • Bachelor's degree in life sciences
  • Experience working in the pharmaceutical industry or a CRO
  • Multilingual capability

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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