Clinical Project Manager

5 days ago

Remote, Australia OPIS S.r.l. Full time

The Clinical Project Manager reports to the Clinical Operations Manager and take full ownership of managing clinical trials from start to finish. This role involves leading project teams, ensuring adherence to timelines and budgets, and proactively identifying and solving issues. You will manage project deliverables, collaborate with cross-functional teams, and mentor junior staff, contributing to the successful execution of clinical studies.

This is a Remote (work from home) position.

Key Responsibilities:

  • Lead and coordinate all project activities, ensuring they meet contractual and regulatory requirements.
  • Manage clinical project teams, ensuring deliverables are completed on time and within budget.
  • Organize and lead meetings with Sponsors, investigators, and internal teams.
  • Ensure site feasibility, qualification, and monitoring activities are performed as per protocol.
  • Oversee the management of study materials, IMP/IP/MD, and vendor deliverables.
  • Collaborate with regulatory teams to expedite the regulatory process and site contract negotiations.
  • Monitor project performance, ensuring KPIs and study milestones are met.
  • Conduct co-monitoring visits and perform study visits when necessary.
  • Manage project budgets and liaise with the finance team on extra-budget needs.
  • Provide mentoring and training to junior staff members and new team members.

Qualifications:

  • Degree in a scientific field.
  • Minimum of 2 years of experience as a Clinical Project Manager.
  • Strong knowledge of ICH-GCP, ISO1455, and clinical trial monitoring techniques.
  • Proven ability to manage local and international projects.
  • Excellent leadership, organizational, and communication skills.
  • Fluent in English.

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 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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