Study Start-Up Project Manager - Canada - FSP

The Start Up Project Manager 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 I will typically take full responsibility for small to medium size 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 I is the leader of the start up sub team for the study, region(s) or countries assigned.

Key Accountabilities:

Project Management

• 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, most typically on studies with a medium to large country and site footprint

• 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, will have ability to form a robust startup strategy and site activation plan for operationally complex studies

• The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study). Responsibility can be for all sites for an entire study or a portion of sites in specific countries in one or more regions

• 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 in turn 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

Plan Delivery

• 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 I 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 first site in study, to site activation complete for 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.

Risk Mitigation

• Co-ordinates 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

Required Skills:

• 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

Required Knowledge and Experience:

• 5+ years experience as a global Study Start-Up clinical trial study manager leading all aspects of Study Start-Up

• Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations

• Extensive knowledge of clinical trial methodology

• Prior Experience Preferred: Demonstrated start up experience, Demonstrated project management experience

Required Education:

• A scientific or technical degree is preferred

• Must have a BS/BA – 5 years relevant experience

• MS/PhD – 3 years relevant experience

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