Australia Job Openings

Pfizer

Study Operations Manager

FULL TIME

October 16, 2024

The Country Study Operations Manager (c SOM) is responsible for regional/country level activities from study startup through conduct and study close. The c SOM partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Site Care Partners, Contracts Lead, Regulatory Affairs, p CRO and others as required to ensure a coordinated approach to study start up, execution and close out. The c SOM has comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. The c SOM 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 c SOM 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 c SOM 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 p CRO 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.
Work independently and exercise their own judgement.
Responsible for management/oversight of 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, 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: 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 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, 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 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 p CRO and sites as applicable
Provides input on Country level Per Subject Costs, localvendor 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 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 (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. 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
Management of local Investigator Meetings including doing presentations as appropriate

BASIC QUALIFICATIONS

Relevant operational clinical trial experience
A scientific or technical degree is preferred along with knowledge of clinical trial methodology
BA/BS 5+ years of relevant experience
MBA/MS 3+ years of relevant 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 experience in managing country level operational activities and/or vendors
Experience in Study and Quality management and working 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 moderately complex processes
Ability to operate 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

Work Location Assignment: Remote

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:

Paid parental leave
Access to Health & Wellness apps
Career Growth Experiences program
Recognition & rewards program
Paid volunteer days
Life Insurance Benefits
Pfizer Learning Academy access to top content providers
Access to flu vaccines & skin checks
Options to purchase additional leave
Salary 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.

Medical

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