Integrated Study Timeline Manager

Integrated Study Timeline Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.

In close collaboration with Global Trial Leads, in this role you will work with cross-functional team members and stakeholders to develop, monitor, and adjust project timelines as needed. You will identify key study activities to drive study timeline development with minimal guidance throughout the study life cycle. You will communicate timeline updates and changes to stakeholders clearly and in a timely manner.

You will manage user access to study timelines and support process improvement initiatives to streamline timelines management.

• 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.

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. Awareness of local country requirements is also an asset.
• Demonstrated successful experience in project/program management and matrix leadership.
  • E.g., timeline/budget management
  • E.g., Risk identification and management
• Preference:
  Sr. clin ops experience, preferred
• 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.

+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, including significant study management support experience (e.g., clinical trial…