Integrated Study Timeline Manager
On-siteBlue Bell, Pennsylvania, United States
Job Summary
Develop and maintain Integrated Study Timelines (IST) for clinical trials using global templates, identifying critical path items and remedilating illogical sequences or gaps. Coordinate cross-functional discussions to customize timelines, run status reports, and monitor project progress to identify delays. Manage user access via SharePoint, create kick-off materials, and support Microsoft Project training while ensuring tasks complete as scheduled. This role requires a Bachelor's degree, 5+ years in pharmaceutical clinical research, and proficiency with Microsoft Project and SharePoint. Full-time position with competitive compensation and comprehensive benefits.
Required Qualifications
- Bachelor's Degree or international equivalent
- Life Sciences
- Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP
- Awareness of local country requirements
- Demonstrated successful experience in project/program management and matrix leadership
- Timeline/budget management
- Risk identification and management
- Sr. clin ops experience
- Excellent communication skills
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Demonstrated successful experience in managing multiple studies concurrently
- Fluent business English (oral and written)
- Proficient with Microsoft Suite (MS Team, Word, Excel, and MSP)
- Understanding of the lifecycle and activities in a clinical trial
- Knowledge and experience with SharePoint including adding users, documents and updating lists within a SharePoint sites
- +3 years of using Microsoft Project (MSP) or Planisware, and comfortable creating, baselining, and maintaining complex trial timelines in MSP or Planisware
- 5+ years' experience in pharmaceutical industry and/or clinical research organization
- 3+ years clinical study management/oversight
- Significant study management support experience (e.g., clinical trial assistant/associate or lead CRA)
- Experience in more than one therapeutic area
Desired Qualifications
- Life Sciences preferred
- Awareness of local country requirements is also an asset
- Experience in early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs
- Experience in more than one therapeutic area is advantageous
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