Overview:
As a Project Manager/Integrated Study Timeline Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities:
What you will be doing:
* Provides subject matter expertise and operational input into creating timelines utilizing Takeda's 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 Takeda 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:
You are:
* Bachelor's Degree or international equivalent required; Life Sciences preferred.
* 3 years of using Microsoft Project (MSP) tool and comfortable creating, baselining, and maintaining complex trail timelines in MSP.
* 5 years experience in pharmaceutical industry and/or CRO, including 3 years clinical study management/oversight.
* 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
* 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.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs
* Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
* Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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