What You Will Be Doing:

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.

Your Profile:

Education:

Bachelor's Degree or international equivalent required; Life Sciences preferred.

Skills:

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.

Experience:

+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 assistant/associate or lead CRA). 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. Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

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. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients' lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you're as driven as we are, join us. You'll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry. Didn't find the role you were looking for? Even if the perfect role isn't available right now, we're always excited to connect with talented individuals. 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