Study Start Up Manager

7 days ago

Emelle Alabama, United States Pharmaceutical Research Associates, Inc Full time
Study Start Up Manager

As a Study Start Up Manager at Pharmaceutical Research Associates, Inc, you will play a critical role in the successful initiation of clinical trials. Your primary responsibility will be to work directly with investigative sites to manage and perform activities associated with study start-up, including regulatory document collection, ethics submission documents, informed consent review, and essential document package review.

Key Responsibilities:
  • Build and cultivate relationships with key study personnel, including Study Coordinators
  • Work directly with Investigative Sites for all aspects of study start-up, including activation timeline development, regulatory document preparation and collection, and assisting with IRB/EC submissions and informed consent review
  • Assist in creation, review, and customization of country/site-specific Informed Consent Forms (ICFs)
  • Assist in drafting and responding to IRB queries and facilitating responses to EC queries
  • Assist in contract and budget negotiations, as necessary
  • Manage translations of relevant study documents
  • Proactively identify site challenges and implement appropriate mitigations
  • Provide regular local status updates to the study team and escalate risks to timelines
  • Manage and track issues and escalations to internal stakeholders
  • Assist in the development of start-up plans
  • Update study-tracking tools and databases with site status
  • May participate in feasibility and/or site identification activities
Requirements:
  • Bachelor's degree with a major in a related field and at least 5 years of experience in study start-up
  • In-depth knowledge of start-up processes and procedures
  • Solid understanding of key regulatory authorities and regulatory requirements
What We Offer:

At Pharmaceutical Research Associates, Inc, we value our employees and offer a range of benefits to support their well-being and work-life balance. These include various annual leave entitlements, a range of health insurance offerings, competitive retirement planning, and a global Employee Assistance Programme. We also offer flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, and subsidised travel passes.

We are committed to providing an inclusive and accessible environment for all candidates and employees. We welcome applications from diverse candidates and are proud to be an equal opportunities employer.

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