Study Start Up Project Manager II- 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 II will typically take full responsibility for medium to large size studies across all regions and countries, or for selected countries or region(s) of a global study where another SUPM is responsible for the site activations of the entire study. The SUPM II is the leader of the start-up sub team for the study, region (s) or countries assigned.

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 alignment with the priority of the study in the overall portfolio and overall expectation to deliver to plan with a high degree of probability

•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

•Typically leads the continual assessment 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

•Expertly integrate the requirements of a protocol amendment(s) to deliver site activations to plan prioritizing optimizing participant recruitment, on request manage the green lighting of sites to implement a protocol amendment after sites are activated for assigned study, region(s) or countries

•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:

• Understanding the critical path activities for all sites based on specific needs of every site and their associated upstream country and study related tasks
• Plan and execute the timely delivery of the investigator initiation package needed for investigational product release to site in partnership with document owners (particularly country level roles), including incorporating the translation requirements into that plan.
• Work in lock step with specialist roles that work directly with sites on the study budgets and contracts to bring this key activity off the site activation critical path
• Co-ordinate across all roles that work directly with site staff to complete site activation readiness tasks (system access and training, protocol related training) to time completion prior to the site initiation visit, or as soon as possible afterwards to reduce or eliminate from the site activation critical path
• Work across roles responsible for the delivery of all physical supplies (investigational product and all non-clinical supplies) to plan and execute delivery to all sites in lock step with all other tasks required for site activation

•Establish and execute communication plans across major teams involved in start-up, focusing on targeted efficient communication pathways that are adapted according to the needs of each team/sub-team

•Participate in early study planning exercises prior to senior leadership endorsed trial operational plan, utilizing internal data analysis and intelligence from peers and in-country operational leaders to inform one or more scenarios of overall site activations over time

Risk Mitigation

•Co-ordinates across the study team and extended partners to deliver site activations to plan (standard target 90% delivered to plan) for the study or regions/countries assigned (typically a medium to large footprint). Assesses the ongoing site activation readiness status as well as proactively identifying and mitigating risks to constantly capitalize on opportunities to optimize site activations to garner the largest positive impact on participant recruitment

•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

•Resolve issues identified by the country start up roles at source or at lowest possible level, triage through to the study management team as appropriate

•Seek to remedy performance concerns with internal and external teams sensitively but promptly, escalating with fairness as appropriate

Process

Improvement

•Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders

Skills:

• Demonstrated clinical research experience
• Demonstrated start up experience
• Demonstrated project management experience
• Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
• Concurrent management of complex processes within and across countries in multiple regions of the world
• Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
• Expert ability to comprehend status and adapt communications across a diverse audience
• Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
• Will use generative artificial intelligence techniques in daily work
• Uses risk management techniques as standard to identify and mitigate key project delivery risks
• Critical thinker with strategic planning, analytical and problem-solving skills that responds positively to rapid change

Knowledge and Experience : 

• 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
• Fluency in English is required

Education:

• Scientific or technical degree is preferred
• BS/BA – 7 years relevant experience
• MS/PhD – 5 years relevant experience

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