Study Start Up Project Manager - FSP

Parexel•Quebec, ON

About The Position

The Start Up Project Manager (SUPM) is responsible for defining, developing, and delivering the global start-up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions, and others as required. The SUPM will be assigned to one or more interventional studies in one or more therapy areas such as oncology, vaccines, internal medicine, rare disease, or inflammation and immunology. The responsibility of the SUPM typically ends when all investigative sites are activated and ready to enroll participants; however, this can extend further into the participant recruitment period to specifically deliver the implementation of protocol amendments across active sites for selected studies. The SUPM will have a comprehensive knowledge of managing and coordinating study start-up activities globally. The SUPM will typically take full responsibility for small to medium-sized studies located in a single country or region, or for selected countries or region(s) within a larger global study where another SUPM is responsible for the site activations of the entire study. The SUPM is the leader of the start-up sub-team for the study, region(s), or countries assigned.

Requirements

Country or Regional start-up exposure/experience in the countries under responsibility across at least two major therapeutic areas.
Technical expertise in use of software (off the shelf and custom) for the management of clinical studies with prowess in using reporting systems (dashboards and associated basic data analysis) to comprehend and communicate status.
Ability to use basic generative artificial intelligence techniques in daily work.
Will use standard risk management methodology to identify and mitigate key risks.
Fluency in English is required.
Extensive global start-up clinical trial/study management experience.
Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations.
Extensive knowledge of clinical trial methodology.
Demonstrated start-up experience.
Demonstrated project management experience.
A scientific or technical degree is preferred.
Must have a BS/BA – 5 years relevant experience.
MS/PhD – 3 years relevant experience.

Responsibilities

Partner with country/site feasibility specialists to incorporate up-to-date intelligence for the planned countries and sites into the overall start-up strategy and site activation plan.
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start-up functions (e.g., site essential document collection, site contracts and budgets) to align country and site activities to form a robust start-up strategy and site activation plan.
Continually assess current and future workload (with other SUPMs on study if applicable) in order to proactively anticipate, problem-solve, and request appropriate changes to the SUPM team assigned to deliver site activations to plan.
As part of the responsibility of delivering site activations to plan, the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study-specific (e.g., Vendor set-up, investigational product supply, etc.) or country-specific tasks (e.g., Regulatory submissions, importer of record for supplies, etc.) that need to be completed in order for site activations to complete.
Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start-up activities for a study.
Lead start-up meetings that facilitate alignment of site selection to activation activities performed by country-level start-up roles with the endorsed trial optimization plan (by senior leadership).
Start-up meetings use the ongoing risk assessment of site activation delivery to form a focused agenda according to risk level, the overall goal is the delivery of major study milestones to plan (e.g., first subject first visit) as well as the overall delivery of major site activations to plan (25%, 50%, and 90% of planned site activations).
The SUPM will work with country-level start-up roles to seek opportunities to accelerate site activations for their study, they will do so while considering the relative priority of their study compared to all concurrent studies in start-up that country-level start-up roles are working on.
Accountable for quality and completeness of start-up timeline plans at study, country, and site level within an enterprise project management (EPM) system, either directly responsible for setting and maintaining timelines (study level) or oversight of other roles setting and maintaining timelines (country and site level).
Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system which build the overall targets for site activation over time.
In conjunction with study management roles, is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies.
Expertly integrate the requirements of a protocol amendment(s) to deliver site activations to plan, on request manage the green lighting of sites to implement a protocol amendment after sites are activated for assigned study, region(s), or countries.
The SUPM is responsible for delivering site activations to plan, for the SUPM this can be for all sites for an entire study or a portion of sites in specific countries in one or more regions.
Responsible for the completeness and quality of site activation timeline plans for every site from investigator initiation package sent for the first site in study, to site activation complete for the last site in study.
Will work with and drive all timeline plan owners (e.g., country start-up roles) to actively manage the site activation timeline plans for their assigned sites.
The SUPM will have a detailed understanding of the timeline for every site.
Coordinates across the study team and extended partners to deliver site activations to plan for the study or regions/countries assigned, assesses the ongoing site activation readiness status as well as proactively identifying and mitigating risks.
Act as a key point of escalations for site activation related issues raised by country-level start-up roles, seeking to firstly resolve issues directly or triage appropriately to other SUPMs on the study or the study management team, will always follow through to resolution.