Start Up Project Manager I

Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
You will be part of Pfizer's medical team and manage the clinical studies. Your project management skills will be leveraged for planning, directing, creating and meet timelines. You will ensure that the clinical studies are within time, budget and scope.
As a Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.
It is your problem-solving ability and patience that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
The Start Up Project Manager (SUPM) will be defining, developing and delivering the global study 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 SUPM scope 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 is typically accountable 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 accountable 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.
SUPM I :

• 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.
• 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).
• Create and oversee the initial baseline and subsequent snapshots of timeline planning within the EPM system which build the overall targets for site activation over time
• 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.
• 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.
• 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.
• 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.

Key Responsibilities:

• 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.
• 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.
• 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.
• 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 be acc of the timeline for every site:
  
  • Familiarity with 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 (particular 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
  • 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
• Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders

Qualifications / Must-Have

• Bachelor's Degree
• Strong previous experience
• Fluency in English
• Demonstrated clinical research experience
• Demonstrated start up and project management experience
• Experience working in the research and development of pharmaceutical industry
• 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

Nice-to-Have

• Master's degree
• Experience in early drug development
• Knowledge of the project management discipline and its application to vaccine/drug development

Work Location Assignment: Remote
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
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