Integrated Study Timeline Manager

Role Description

We are currently seeking a Project Manager to join our diverse and dynamic team. Working as an Integrated Study Timeline Implementation Manager exclusively assigned to a Pharmaceutical Company, you will lead development, customization, and maintenance of the Integrated Study Timelines (IST) for clinical trials using global timeline templates.

• Provides subject matter expertise and operational input into creating timelines utilizing the integrated study timeline templates.
• Attend and actively participate in study execution team meetings for activities related to timelines.
• Coordinate and lead study timeline related and cross-functional discussions to support customization and maintenance of timelines through IST alignment meetings.
• Identification of critical path items related to timelines management.
• Identification and remediation of illogical sequence of events, gaps, duplicate or conflicting activities for study timelines.
• Run timeline status reports and post updated timelines regularly.
• Create SharePoint Users roles and provide access to study team members for timeline materials.
• Monitor project progress and identify potential delays or roadblocks.
• Work with cross functional team members to ensure tasks are completed as scheduled.
• Create all material related to IST (i.e., Kick off Meeting Materials) development for customization and handover.
• Review of study related material and protocol to drive discussion related to study timelines.
• Support Microsoft Project (MSP) training and creation of tools needed for MSP timelines.
• Develop and maintain templates and tools related to global timeline templates.
• Support open house-training sessions for timelines template and MS project utilization.
• Collaborate with the study team to update the study timelines during all stages of a clinical trial study.
• Provide expertise for MSP and timeline related processes and documents.

Qualifications

• Bachelor’s Degree or international equivalent required; Life Sciences preferred.
• Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
• Demonstrated successful experience in project/program management and matrix leadership.
• Excellent communication skills as needed for facilitation, negotiating, risk management.
• 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).
• Understand the lifecycle and activities in a clinical trial.
• Knowledge and experience with SharePoint including adding users, documents and updating lists within a SharePoint sites.

Requirements

• +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, including 3+ years clinical study management/oversight.
• Experience could include either 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.

Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.