1+ months

Country Trials Manager

Pfizer
Taipei
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**ROLE SUMMARY**

The Country Trials Manager is responsible for study startup deliverables for assigned studies at a country level that are of moderate to high complexity. The Country Trials Manager partners with the Study Start Up Project Manager, Study Manager, Site Relationship Partner, Site Operations and Activation Partner, Contracts Lead, Regulatory Affairs, CRO representatives) and others as required. The Country Trials Manager provides leadership and country strategic planning and organization skills to ensure the delivery of operational Start up aspects of 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.

Accountable for the execution of:



+ Country level implementation of Startup and Site Activation Plans

+ Country level Recruitment Strategy

+ Timely and quality EC/RA Submissions

+ Communication with internal stakeholders as listed above to ensure efficient and timely study startup delivery at a country level



**ROLE RESPONSIBILITIES**

**Responsible for Study and Site Start-up on a Country level:**



+ Manages the study start up process in countries assigned.

+ 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 to global Study T eam during planning.

+ Is accountable for delivery of start up and site activation 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).

+ Highlights deviations and risks in startup and site activation plans to relevant parties, develops and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation (both at the study and site level).

+ Leader of the Local Study Team (core members: Country Trials Manager, Site Relationship Partner, Site Operations and Activation Partner, ad hoc members: Contracting, Regulatory, Medical Affairs colleagues and other key stakeholders as required).

+ 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 GSSO and Regulatory colleagues in country colleagues to agree on submission strategy to HAs and Ethic committees.

+ Provides Global Teams with local intelligence. Acts as the main point of contact for all study-level questions for the Local Study Team, liaising with and escalating to appropriate global roles/teams. Follows up on country level issue status to ensure resolution. Identifies start up country level trends to improve start up processes as needed.

+ Ensures audit/Inspection readiness during start-up.

+ Manages country level Sign i ficant Quality Events occurring during Site and Study Startup

+ Leads effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets.

+ Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable

+ Mentors/coaches and helps onboard other Clinical Trials Managers

+ Identifies and communicate study startup mitigation plans that may be effective across country clusters

+ Acts as a Subject Matter Expert in areas linked to study start up

+ Leads operational effectiveness initiatives at country/cluster level



**Responsible for Study and Site** **Start-up Country Operational aspects:**



+ PTA and SIV report review

+ Collects Country level documents (e.g. Insurance documents, LOA if required) required for submission/SIVs

+ Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CSA submissions

+ Supports Clinical Study Agreement and budget negotiations and setup of site payment tools

+ Country and site level PTMF setup

+ Provides country level documents to PTMF and Investigator Site File (ISF) and ensure country level PTMF completeness during study startup

+ Country level ICD creation and Global Review and Approval Form (GRAF) completion and site level ICD creation and GRAF completion, if applicable

+ Country level IP/equipment/ancillary supplies management including Import/Export License management

+ Supports implementation of new tools and technologies

+ Identify/contract/Manage/Oversee local vendors or facilities as per protocol

+ Investigator Meeting support



**BASIC QUALIFICATIONS**

**Training and Education**



+ A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc or equivalent or above

+ Extensive operational clinical trial experience

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

+ English and region/country local language is required.



**PREFERRED QUALIFICATIONS**

**Prior Experience**



+ + 7 years of clinical research experience and/or study management/startup project manager experience

+ Demonstrated knowledge of site selection, site activation, site readiness interdependencies

+ Demonstrated knowledge of clinical trial methodology and the drug development process

+ Demonstrated experience leading 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 Site Activation 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



**Behavioral Competencies**



+ Seeks to develop an integrated view of key issues to shape decisions and strategy development and suggest ways to improve

+ Proactively manages change by identifying opportunities and coaching self and others through the change

+ Demonstrated ability to introduce new ideas and implement them

+ Effectively overcome barriers encountered during the implementation of new processes and systems

+ Builds effective relationships with customers and other stakeholders

+ Works well across country boundaries, respecting communication and cultural differences in interpersonal relationships

+ Acts as a mentor for other Country Trials Managers.



\#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical



\#LI-PFE
Posted: 2021-03-09 Expires: 2021-05-10
Sponsored by:
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Country Trials Manager

Pfizer
Taipei

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