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Clinical Development Director

2 months ago

Carolina, United States OPIS s.r.l. Full time
Job DescriptionJob Description

We are seeking a highly skilled and motivated Clinical Development Director to join our dynamic team. The successful candidate will play a pivotal role in managing Request for Proposals (RFPs) and supporting our Business Development team in pre-award stage. This position involves close collaboration with various departments, ensuring strategic and operational excellence in our clinical studies.
This is a fully home based role in the USA.

Key Responsibilities:

  • RFP Management:

    • Act as the main point of contact within Clinical Operations during the RFP process.
    • Provide strategic operational inputs and work closely with Clinical Operations Managers, Project Managers, Proposal team, Vendor team, Medical team, and Proposal Writer.
    • Oversee the RFP process from a project management perspective, including preparing Gantt charts, involving relevant functions, and ensuring deadlines are met.

  • Client & Internal Collaboration:

    • Participate actively in client meetings, presentations, and face-to-face meetings with sponsors.
    • Attend internal RFP calls and provide strategic inputs from a clinical operations perspective.
    • Support business growth by working closely with the Business Development team.
    • Prepare slides for client meetings and bid defense meetings.

  • Vendor Management:

    • Work closely with the vendor selection team to define assumptions and review quotations.
    • Oversee vendor activities in collaboration with Clinical Operations Managers, organizing governance meetings as needed.
    • Define and monitor KPIs in vendor contracts.

  • Project Support:

    • Provide expert operational guidance to Project Managers.
    • Ensure compliance with SOPs, contracts, and regulations.
    • Assist with the operationalization of studies and provide strategic support.

  • Training & Development:

    • Assist with the onboarding of new direct reports and act as a mentor when needed.
    • Participate in audits/inspections and support team in managing CAPA plans.

Requirements:

  • Degree in a scientific field.
  • At least 7 years of experience in the clinical research field.
  • Strategic mindset to support business growth.
  • Strong negotiation, customer service, and team leadership skills.
  • Excellent organizational, planning, and budget management skills.
  • Ability to prioritize and manage multiple high-value projects simultaneously.
  • Strong project management and problem-solving skills.
  • Willingness to travel internationally.
  • Excellent knowledge of the English language.

What we offer:

We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.

Please read the information notice on the processing of personal data in the candidates information section of our company website.

Who we are:

OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.

OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.

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