Country Study Operations Manager

The Country Study Operations Manager (cSOM) is responsible for regional/country level activities from study start-up through conduct and study close. The cSOM will be assigned one or more studies and will be tasked with taking on several responsibilities in support of the larger Study Management deliverables. The cSOM partners with the Global Study Manager, sSOM, 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.

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 Start-up and Site Activation Plans

• Regional/Country level Recruitment Strategy

• Responsible for development of Country level plans

• Communication with 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 and be a resource for others.

• Responsible for management/oversight of regional/country level activities from study start-up 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 Start-up 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 start-up 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 on submission strategy to Health Authorities and Ethic Committees

• Utilizes roles in country such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered

• Follows up on region/country level issue status to ensure resolution.

• Identifies country level trends to improve deliverables processes as needed

• Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies

• Ensures audit/Inspection readiness during start-up and conduct

• Manages applicable Quality Events with local team as applicable and required

• Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets

• Responsible to drive and ensure delivery of data cleaning deliverables for sites as applicable

• Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable

• May act as a Subject Matter Expert

• May lead operational effectiveness initiatives at country or regional level

• Responsible for PTA and SIV report review for reports completed by the Site Care Partner

• Supports implementation of Pfizer's Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)

• Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines

• Drives applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness

• Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions

• Ensures applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required

• Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)

• Support Identification, contract development and management of local vendors or facilities as per protocol

• Investigator Meeting support and management including doing presentations as appropriate

• Management of local Investigator Meetings including doing presentations as appropriate

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 communicating timelines. You will ensure that the clinical studies are within time, budget and scope. 

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. 

It is your problem solving ability and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe. 

How You Will Achieve It 

• Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division. 

• Oversee the overall execution of clinical studies and be accountable for the development of realistic detailed study start-up and monitoring plans. 

• Oversee and support study start up activities at the country level, including review of key documents and providing support to address regulatory and/or ethics committee questions. Forecast and manage the Clinical Trial Budget. 

• Manage full studies for Operational Study Management or manage a unique part of a larger study. 

• Serve as primary point of contact for study decisions related to the protocol, data collection and volunteer activities. 

• Approve and oversee drug supply management and manage flow of drug supply to the sites. 

• Partner with key team members to manage the program to achieve key milestones within time, cost and quality parameters. 

• Work with functional lines and directly with Contract Research Organization (CRO) line functions to resolve or triage site level issues. 

• Share and escalate plan deviations to Clinical Project Manager and study team. 

• Help to address Significant Quality Events or other quality issues at patient and/or site level. 

• Lead the data integrity and data quality activities for assigned protocols. 

• Provide regional and cross-regional insights on study-site performance and trends to / from the study team. 

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Qualifications 

Must-Have 

• Bachelor's Degree 

• 5+ years’ experience 

• Demonstrated project management / leadership experience 

• ​Experience working in the research and development of pharmaceutical industry 

• Experience conducting, managing or participating in regulatory inspection processes 

• Country level cultural awareness and strong interpersonal skills 

• Excellent communication skills, both written and verbal in English 

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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 - Field Based