Job Description

The Study Operations Manager II is accountable for study and regional/country level activities from study startup through conduct and study close. The Study Operations Manager will be assigned one or more studies and will be tasked with taking on several accountabilities in support of the larger Study Management deliverables. The Study Operations Manager II partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Site Care Partners, Contracts Lead, Regulatory Affairs, CRO and others as required to ensure a coordinated approach to study start up, execution and close out.

The Study Operations Manager II has exceptional knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. The Study Operations Manager II 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 Study Operations Manager II may be relied upon to independently take on the closing out of one or more studies post database lock. Provides back up to or takes on the tasks of Global Study Manager as needed.

Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. The Study Operations Manager II will be fully accountable for tasks as designated on the study by the Global Study Manager. The Study Operational Manager II will be able to work independently and exercise their own judgement and be a resource for others.

ROLE RESPONSIBILITIES

Operational Study Management Accountabilities

• Management/oversight of study and regional/country level activities from study startup through conduct and study close
• May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee CRO accountable for these activities as applicable
• 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 CRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
• Partners 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/Regional Study Operations Team (core members: (Lead) Site Care Partners, Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, etc.
• Ensures compliance to relevant Global and Local, internal, and external requirements and regulations
• Ensures timely communication bidirectionally between the global and local/regional study team.
• Provides protocol level guidance and support to responsible Local/Regional Study Team members as applicable.
• 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
• Acts as the study level point of contact for all study-level questions for the Local/Regional Study Team, ensuring resolution at lowest level, and when needed liaising with and escalating to appropriate global roles/teams
• 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 CRO and 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
• PTA and SIV report review for reports completed by the Site Care Partner
• Support to EC/RA and other relevant (e.g., radiation, biobank) submissions and deficiency/query replies for initial and subsequent CTA submissions within required timelines
• Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
• Aids the 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
• Other duties as delegated by the GSM

QUALIFICATIONS

Training and Education

• Extensive clinical trial operations experience
• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
• BA/BS and in-depth, relevant, demonstrable experience, or MBA/MA/MS and substantial demonstrable experience
• Working knowledge of Good Clinical Practices, clinical and regulatory operations, and environment in countries under responsibility
• English is required.

Prior Experience

• Oncology Therapeutic Area Experience (relevant experience preferred)
• Demonstrated clinical research experience and/or study management 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

Skills and Technical Competencies

• Expertise in the use of study/site dashboard and reporting tools
• Risk Identification & Mitigation, Strategic Planning, Analytical and Critical Thinking Skills, Critical Path Analysis
• Ability to adapt to changing technologies and processes
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

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\xe2\x80\x99s 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 \xe2\x80\x93 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 Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

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