ROLE SUMMARY

The Country Study Operations Manager (cSOM) is responsible for regional/country level activities from study startup through conduct and study close. The cSOM partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Site Care Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out. The cSOM has comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. The cSOM 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. The cSOM ensures the operational delivery of responsible tasks within the assigned studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.

ROLE RESPONSIBILITIES

Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. The cSOM will be accountable and responsible for tasks as designated on the study by the Global Study Manager which may include:

• Regional/Country level implementation of Startup and Site Activation Plans
• Regional/Country level Recruitment Strategy
• Responsible for development of country 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 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.
• Work independently and exercise their own judgement.
• Responsible for management/oversight of regional/country level activities from study startup through conduct and study close
• May manage the study start up process in countries assigned and/or oversee pCRO responsible for these activities as applicable
• Through the Site Care Partner, 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 Site Care Partner to Global Study Manager during planning
• Is accountable for overseeing 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

QUALIFICATIONS

• BSc/MSc degree is required. A scientific or technical degree is preferred along with knowledge of clinical trial methodology.
• 5+ years of relevant experience
• Relevant operational clinical trial experience.
• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility.
• Demonstrated clinical research experience and/or study management/startup project manager experience.
• Demonstrated experience in managing country level operational activities and/or vendors.
• Experience in Study and Quality management and working in a matrix management environment.
• Expertise in the use of study/site dashboard and reporting tools.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization.
• Detail oriented & possesses technical expertise.
• Ability to manage moderately complex processes.
• Risk Identification & Mitigation.
• Strategic Planning, Analytical and Problem-Solving Skills.
• Critical Path Analysis.
• Ability to adapt to changing technologies and processes.
• English is required.

Work Location Assignment: Remote

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To apply please visit our website www.pfizercareers.com and search job Study Operations Manager id 4922782.