• Regional/Country/Study level implementation of Startup and Site Activation Plans
• Regional/Country/Study level Recruitment Strategy
• Responsible to support the development of study level plans
• Communication with the local team and internal stakeholders and p CRO 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.

• 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 and/or oversee p CRO responsible for these activities as applicable
• Through the Site Care Partner/Country Trial Manager or p CRO 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 p CRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
• Is accountable for overseeing p CRO 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 (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 (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 p 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
• Responsible to drive and ensure delivery of data cleaning deliverables for p CRO 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)
• 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 p CRO 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 reconciliation and completeness actions
• Ensures p CRO 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. e Consent, e ISF, Remote Source Access, remote SDV/SDR, i Connect, 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

• A scientific or technical degree at Bachelor or Master level
• Excellent knowledge of clinical trial methodology
• Demonstrated clinical research experience and/or study management/startup project manager experience
• Demonstrated experience in managing country level operational activities and/or vendors
• Experience in Study and Quality management and working in a matrix management environment

• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility

• English is required. Danish is strongly preferred. Written and verbal.

• Expertise in the use of study/site dashboard and reporting tools
• Detail oriented & possesses technical expertise
• Ability to manage moderately complex processes
• Risk Identification & Mitigation
• Strategic Planning, Analytical and Problem-Solving 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

• Requires comprehensive knowledge of own discipline and good knowledge of others and applies these skills to ensure the study can meet its goals
• Supports an environment where innovation is standard taking appropriate risks to advance innovative processes
• Develops ideas and leads moderately complex projects
• Exercises own judgment and is a resource for others.

• For detailed questions please contact hiring manager via email Amy.L.Jones@pfizer.com
• Learn more about Pfizer Denmark on www.pfizer.dk
• Applications to be submitted in English, no later than October 30th.

Medical