ROLE SUMMARY

The Country Senior 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, sCOM, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Excellence Partners, Site Relationship Partners, 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 exceptional knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. The cSOM provides leadership and strategic planning and organization skills to ensure the operational delivery of 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 cSOM may be responsible to independently take on the closing out of one or more studies post database lock.

ROLE RESPONSIBILITIES

Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. The cSOM will be fully 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 Strategybe a resource for others.
• Responsible for management/oversight of regional/country level activities from study startup through conduct and study close.
• May manage the 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.
• Leader of the Local Study Team (core members: Site Care Partners, 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, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees.

QUALIFICATIONS

• BSc/MSc degree is required. A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology.
• 7+ years of relevant experience.
• Extensive operational clinical trial experience.
• Demonstrated clinical research experience and/or study management/startup project manager experience.
• Demonstrated knowledge of site selection, site activation, site readiness interdependencies.
• Demonstrated knowledge of clinical trial methodology and the drug development process.
• Demonstrated experience participating on cross functional teams.
• Demonstrated experience in Project Management and Quality Management
• Demonstrated experience in a matrix management environment.
• Expertise in the use of study/site dashboard and reporting tools.
• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility.
• 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 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 Senior Study Operations Manager id 4922786.