Country Study Operations Manager II

at  Pfizer

Job Description: Country Study Operations Manager II (cSOM II)
The Study Operations Manager is responsible 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 responsibilities in support of the larger Study Management deliverables. The Study Operations Manager partners with the Global Study Manager, 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 Study Operations Manager has exceptional knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. They provide 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. They may be responsible to independently take on the closing out of one or more studies post database lock. Provides back up to or takes on the responsibilities of Global Study Manager as needed.

Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. They will be fully accountable and responsible for tasks as designated on the study by the Global Study Manager which may include:

• Regional/Country/Study level implementation of Startup and Site Activation Plans (through SUPM or pCRO if assigned)
• Regional/Country/Study level Recruitment Strategy
• Responsible for development of study 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 study and/or 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 Study Operational Manager will be able to work independently and exercise their own judgement and be a resource for others.

Job Responsibilities

Operational Study Management

• Responsible for 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 pCRO responsible for these activities as applicable
• Through the Site Care Partner/Country Trial Manager or pCRO 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 pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
• Is accountable for overseeing pCRO and/or Country Trial Manager/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
• Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible 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 pCRO 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
• Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and 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 pCRO and/or 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 pCRO and/or 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

QUALIFICATIONS

Training and Education

• Extensive operational clinical trial experience
• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
• BA/BS with expert applicable knowledge and relevant experience
• MBA/MS with solid advanced and demonstrable experience
• BS/BSc/MS/MSc

Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
English is required.

Prior Experience

• Demonstrated clinical research experience and/or study management/startup project manager experience
• Demonstrated knowledge of
• site selection, site activation, site readiness interdependencies
• clinical trial methodology and the drug development process
• Demonstrated experience
• participating on cross functional teams
• in Project Management and Quality Management
• in a matrix management environment

Skills and Technical Competencies

• Expertise in the use of study/site dashboard and reporting tools
• Detail oriented & possesses technical expertise
• Ability to manage complex processes
• Ability to manage in a matrix environment
• Risk Identification & Mitigation
• Strategic Planning, Analytical and Problem-Solving Skills
• Critical Path Analysis
• Excellent communication skills, both written and verbal
• 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

Behavioural Competencies

• Requires exceptional knowledge of own discipline and advanced knowledge of others and applies these skills to ensure a Sub Business Unit/Sub Operating Unit meets its goals
• Creates an environment where innovation is standard taking appropriate risks to advance innovative processes
• Develops ideas and leads complex projects across Sub Business Unit/Sub Operating Unit
• Develops innovative solutions to complex problems impacting a Sub Business Unit/Sub Operating Unit
• Exercises own judgment and is a resource for others. Works independently with assignments often self-initiated.

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 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!
Medical

• Regional/Country/Study level implementation of Startup and Site Activation Plans (through SUPM or pCRO if assigned)
• Regional/Country/Study level Recruitment Strategy
• Responsible for development of study 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 study and/or 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 Study Operational Manager will be able to work independently and exercise their own judgement and be a resource for others