Study Operations Manager

The Country Study Operations Manager (cSOM) is responsible for regional/country level activities from study startup through conduct and study close.
The cSOM partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, 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 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.
The cSOM ensures the operational delivery of responsible tasks within the assigned studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.
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 PlansRegional/Country level Recruitment StrategyResponsible for development of country level plansCommunication 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 plansResponsible for country vendor management and oversight including follow up and coordination of vendor deliverablesResponsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc.Work independently and exercise their own judgement.Responsible for management/oversight of regional/country level activities from study startup through conduct and study closeMay manage the study start up process in countries assigned and/or oversee pCRO responsible for these activities as applicableThrough the Site Care Partner, supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirementsProvides country level input on Startup and Recruitment milestones as provided by Site Care Partner to Global Study Manager during planningIs 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 mitigationLeader of the Local Study Team (core members: Site Care Partners, 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 regulationsEnsures 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, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic CommitteesUtilizes roles in country such as 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 consideredFollows up on region/country level issue status to ensure resolution.Identifies country level trends to improve deliverables processes as neededUtilizes 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 studiesEnsures audit/Inspection readiness during start-up and conductManages applicable Quality Events with local team as applicable and requiredCoordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targetsResponsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicableProvides input on Country level Per Subject Costs, local vendor costs and other fees where applicableMay act as a Subject Matter ExpertMay lead operational effectiveness initiatives at country or regional levelResponsible for PTA and SIV report review for reports completed by the Site Care PartnerSupports 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 timelinesDrives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completenessProvides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actionsEnsures 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 requiredSupports 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 protocolInvestigator Meeting support and management including doing presentations as appropriateManagement of local Investigator Meetings including doing presentations as appropriateBASIC QUALIFICATIONS Relevant operational clinical trial experienceA scientific or technical degree is preferred along with knowledge of clinical trial methodologyBA/BS 5+ years of relevant experienceMBA/MS 3+ years of relevant experienceWorking knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibilityEnglish is required.Prior Experience Demonstrated clinical research experience and/or study management/startup project manager experienceDemonstrated experience in managing country level operational activities and/or vendorsExperience in Study and Quality management and working in a matrix management environmentSkills and Technical Competencies Expertise in the use of study/site dashboard and reporting toolsDetail oriented & possesses technical expertiseAbility to manage moderately complex processesAbility to operate in a matrix environmentStrategic Planning, Analytical and Problem-Solving SkillsExcellent communication skills, both written and verbalAbility to adapt to changing technologies and processesWork Location Assignment: Remote
At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including: Paid parental leaveAccess to Health & Wellness appsCareer Growth Experiences programRecognition & rewards programPaid volunteer daysLife Insurance BenefitsPfizer Learning Academy access to top content providersAccess to flu vaccines & skin checksOptions to purchase additional leaveSalary packaging & novated lease options*Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate.
With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for.
We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
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