Job Description
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.
- May 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.
- May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives.
- Accountable for managing any study specific partners and/or vendors.
Core Skills
- Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH).
- Ability to manage multiple competing priorities with good planning, time management and prioritization skills.
- Solid understanding of the principles of project planning & project management.
- Good analytical skills to drive operational milestones.
- Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.
- Interact with key stakeholders across department, division, and company. Role requires a proactive approach and leadership driving toward study goals.
- Applying 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.
- Intermediate knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.).
Minimum education required:
Bachelor’s degree + 5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master’s + 3 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD. Degree in life sciences, preferred.
Required experience and skills:
- Experience in conducting global clinical trials, including trial initiation through database lock.
- Experience in conducting clinical trials in gastrointestinal, rheumatologic and/or dermatologic disorders preferably autoimmune/immune mediated disease trials.
- Experience with external expert review of participant eligibility (e.g., QC inclusion and exclusion criteria).
Preferred experience and skills:
- Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.
- Managing team directly supporting the clinical trial.
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