The Start Up Project Manager (SUPM) is responsible for 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 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.

• 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).
  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
  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.

JOB RESPONSIBILITIES
Indicate the primary responsibilities critical to the job.
SUPM I
 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.
 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.
 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 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 (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

 Work across roles 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 key stakeholders

Education
 Extensive global start up clinical trial/study management experience
 Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
 A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
 BS/BA – 5 years relevant experience
 MS/PhD – 3 years relevant experience
 Fluency in English is required

PREFERRED QUALIFICATIONS
SUPM I
Demonstrated clinical research experience
 Demonstrated start up experience of 6-8yrs
 Demonstrated project management experience of 10yrs