Start Up Project Manager II- FSP Job at Parexel

Job Description

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.

Job Responsibility

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)
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)
The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
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
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
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
Act as a key point of escalations for site activation related issues raised by country level start up roles
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
Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders

Requirements

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

Parexel - All Job Offers

Select Country

Start Up Project Manager II- FSP

Job Description

Job Responsibility

Requirements

Looking for more opportunities?

Start Up Project Manager II- FSP

Global Site Start Up II - Spain/Poland/Serbia/Romania - FSP

Statistical Programmer II - FSP

Senior Clinical Site Manager

Physician - Structural Heart Interventional Cardiologist

Assistant Executive Housekeeper

Supported Living Support Worker

Wellbeing Officer

Assistant Events Manager

Our AI answers in your language