Clinical Trial Operations Lead/Clinical Trial Manager

About the role

This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials.

Job Responsibilities

• Responsible for the operational planning, feasibility, and execution of a clinical trial.
  • May serve as the clinical trial team lead.
  • Lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities).
  • Leads team for timeline management, risk identification and mitigation, issue resolution.
  • Facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives.
  • Manage any study specific partners and/or vendors.

Core Skills

• Demonstrated ability to drive and manage operational activities on clinical protocols.
• Ability to manage multiple competing priorities with good planning, time management and prioritization skills.
• Solid knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (ICH)).
• Good analytical skills to drive operational milestones.
• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.
• Proactive approach and leadership driving toward study goals.
• Leadership skills to processes, leading meetings, and influencing peers in a matrix environment.
• Problem solving, prioritization, conflict resolution, and critical thinking skills.
• Strong communication, writing, and presentation skills.

Education/Experience

• A minimum of a Bachelor's Degree and 5+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
• A Master's Degree and 3+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
• A PhD/PharmD Degree.
• Preferred: A Degree in life sciences.
• Ideal Candidate Would Have Experienced conducting global clinical trials, including trial initiation through database lock.
• Experienced managing and driving operational activities on protocols for immunology related clinical trials.
• Experienced with imaging vendors, clinical outcome assessments, biomarker sample collection and management, central labs and external data monitoring committee for immunology clinical trials.
• Highly Preferred: Experienced conducting clinical trials for Gastroenterology, Dermatology, Rheumatology, especially autoimmune or immune-mediated disorders clinical trials.

Required Skills

• Clinical Data.
• Clinical Immunology.
• Clinical Operations.
• Clinical Research.
• Clinical Study Design.
• Clinical Trial Compliance.
• Clinical Trial Management.
• Clinical Trials.
• Ethical Standards.
• ICH GCP Guidelines.
• Project Management.
• Project Planning.
• Regulatory Compliance.
• Risk Management.

Preferred Skills

• Intermediate knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.).
• Experienced conducting global clinical trials, including trial initiation through database lock.
• Experienced managing and driving operational activities on protocols for immunology related clinical trials.
• Experienced with imaging vendors, clinical outcome assessments, biomarker sample collection and management, central labs and external data monitoring committee for immunology clinical trials.
• Highly Preferred: Experienced conducting clinical trials for Gastroenterology, Dermatology, Rheumatology, especially autoimmune or immune-mediated disorders clinical trials.