Country Study Operations Manager I

hace 2 meses

Ciudad de México CDMX Pfizer A tiempo completo

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, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.

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

How You Will Achieve It

The Country Study Operations Manager I (cSOM) is responsible for regional/country level activities from study startup 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, 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 comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team.

The cSOM 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 cSOM 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 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.
- The cSOM will be ablet to work independently and exercise their own judgement and be 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

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