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 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

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Qualifications

Must-Have

Bachelor's Degree

5+ years' experience

Applicable pharmaceutical industry experience

Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations

Demonstrated project management / leadership experience

Experience with CRO oversight

Ability to evaluate, interpret and present complex issues and data to support risk

Excellent communication skills, both written and verbal; must be fluent in English

Effective decision maker, analytical and solution-oriented

Proficiency in Microsoft Office Suite

Nice-to-Have

Master's degree.

Broad based experience in clinical research

Strong knowledge of Therapeutic Area, subject matter expertise and international experience

 
Work Location Assignment: Remote

Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!