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Study Operations Manager I

3 months ago

New York, New York, United States Pfizer Full time

ROLE SUMMARY


The Study Operations Manager will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close.

The Study Operations Manager has responsibility for study

management aspects of assigned studies of limited complexity (e.g. single country, a small number of countries/sites) or manage a unique part of a larger study (e.g. recruitment and retention). The Study Operations Manager will be


assigned to one or more studies and will be tasked with taking on responsibilities in support of Global Study Managers, other Study Operational Managers and the larger Study Management delivery of the study.

The Study Operations Manager may partner with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Care Partners, Site Excellence Partners, Site Relationship Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out.


The Study Operations Manager has comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team.

The Study Operations Manager I may lead specific parts of the project or drive specific countries.

They may help guide the Study Management strategy by inputting local intelligence and providing accurate updates on tasks delegated to them in order to support establishment of critical path activities and risks.

They will ensure the operational delivery of responsible tasks within one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.

The Study Operations Manager may be responsible to independently take on activities with instruction provided as needed. They may lead and guide the closing out of one or more studies of low complexity post database lock.

Accountable for the execution of tasks of moderate complexity and developing solutions to problems as needed to support deliverables.

The Study Operations Manager will be accountable and responsible for tasks as designated on the study by the Global Study Manager which may include:

  • Regional/Country/Study level implementation of Startup and Site Activation Plans (through SUPM or pCRO if assigned)
  • Regional/Country/Study level Recruitment Strategy
  • Responsible to support the development of study level plans
  • Communication with the local team and internal stakeholders and pCRO as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
  • Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
  • Responsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc.
  • The Study Operational Manager will be able to work independently and exercise their own judgement

JOB RESPONSIBILITIES

  • Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
  • May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable
  • Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
  • Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
  • Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
  • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations
- to Study Teams including offering options for mitigation

  • Leader of the Local Study Team (core members: (Lead)
Site Care Partners Clinical Trial Assistant, ad hoc members:
ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)

  • Ensures compliance to relevant Global and Local, internal and external requirements and regulations
  • Ensures timely communication bidirectionally between the global and local study team.
  • Provides protocol level guidance and support to responsible Local Study Team members as applicable.
  • Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree