SR. Study Start Up Specialist I

Pharmaron

  • Piscataway, NJ
  • Permanent
  • Full-time
  • 30 days ago
  • Apply easily
Are you ready to embark on a journey with a team that's passionate about making a difference?Look no further - Pharmaron is looking for you to join us as our Senior Study Start up Specialist you're craving a role that offers challenges, growth, and meaningful impact, then this is the opportunity you've been waiting for.This is a remote role USA role.What you will do:As our Senior Study Start Up Specialist at Pharmaron you will play a pivotal role which requires a dynamic professional with a strong background in Study Start up. The Study Study Start-Up Specialist is responsible to coordinate clinical trial start-up activities and support the Study Start Up Manager in sponsored clinical trials.In addition:
  • Research local requirements for documentation of IRB/EC submission approvals and subsequent follow-up documentation.
  • Assist with IRB/EC submissions as required. Provide updates of local processes and requirements to Regulatory Intelligence portal.
  • Arrange/review translations of regulatory documents as required.
  • Ensuring ICH/GCP compliance and interpreting and implementing regulations, guidelines, and standards relevant to clinical trials.
  • Liaise with study sites regarding essential document collection and, as required by country, site contract/budget negotiations.
  • Assist with IRB/EC submissions as required.
  • Review of Master site specific Informed Consent format a site level, QC done by Manager SSU according to FDA regulation.
  • Review Study documents as required, e.g. patient directed materials.
  • Provide regular local status updates to Study Start Up manager; updates appropriate study tracking tools with local essential document and ethics committee status when required.
  • Assist project teams with site selection and Feasibility activities as required.
  • Ensure all relevant documents are submitted to the Trial Master File (TMF) as per SOP/Sponsor requirements.
  • Assist in vendor management activities and implementation of CDAs with new vendors.
  • Collaborating with cross-functional teams to ensure compliance with applicable regulatory requirements.
What We're Looking For:You'll bring not just your scientific expertise, but also your outstanding abilities in relationship-building and your drive for delivering inventive solutions.Qualifications and Experience:
  • Bachelor's degree preferred and can be in regulatory or life science or relevant field.
  • 5 or more years' experience in Clinical Operations and / or study-Start-up within a CRO，or pharmaceutical company.
  • Be familiar with FDA, ICH-GCP and relevant.
  • To have strong ability in organization, coordination, communication, and management.
  • Experience in Contracts and budget management would be advantageous
Why Pharmaron?Pharmaron is a premier contract research organization that offers a broad spectrum of R&D and manufacturing service capabilities throughout the entire drug discovery, preclinical, clinical development and commercialization process. With a workforce of over 20,000 professionals and operations spanning the U.S., U.K and China.Our Culture: You'll thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators.Your benefit package: As part of our commitment to your well-being, we offer a comprehensive benefits package, including medical, dental, and vision insurance with significant employer contributions. Planning for your future is made easier with our 401k plan and employer match. Plus, you'll have access to an Employee Assistance Program to support you in work and life.EEO/AA Statement:As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.#LI-ZS1

Pharmaron