Trial Operations Manager

Major accountabilities:

- Partners and agrees with GPT/GCT/ICT/CTT on trials execution plans and timeline

commitments in alignment with Trial Monitoring strategy and on behalf of the Trial
Monitoring organization to achieve global and regional/local business. Communicates
planned milestones to Trial Monitoring stakeholders and update GCT/ICT/CTTs on
operational activities at the Region/CO level, during the course of the trials to meet
GPT Objectives
- Participates in the development of innovative solutions in clinical trial planning and

execution, including country, site and patient engagement to ensure the delivery of
assigned studies on time
- Provides ongoing information and regular updates to the Trial Monitoring organization,

including remediation actions - Is a core member of the assigned TOM Development Unit Team

- Actively participates in the development of reporting methodologies, and implements

performance reporting for trial monitoring, ensures accurate and complete operational
data within corporate systems (ie CTMS, IMPACT)
- May be the delegate of TOM Development Unit Head for specific teams or activities

Allocation, initiation and conduct of trials
- Is responsible to have trials execution according to enrolment commitment and

timelines delivered per established GDD key performance indicators
- Develops planning for prospective management of clinical trials including operational

risks for each phase of the trial (Feasibility/allocation, Start-up, Data collection and
cleaning) using available internal and external resources (patients' incidence,
competitive landscape regional strategies, data, statistical plan)
- Leads trial allocation process to ensure adequate patient accessibility and alignment

with Regional and Country strategies, including re-allocation or corrective action when
needed
- Reviews, approves, and ensures updates to CCGs as appropriate during trial conduct.

Performs User Acceptance Testing for EDC system. Contributes to the development of
the Data handling and review plans
- Leads/co-chairs with study lead meetings with local study teams, is a member of the

global clinical trial team and represents Trial Monitoring, is the single point of contact
for the conduct of assigned trials
- Is the author of the monitoring plan and following updates (as needed), trains monitors

on the monitoring plan and updates
- Distributes regulatory documents such as Protocol, ICFs, IBs and all related

Amendments to COs
- Facilitates development of trial level operational training materials within CTT with

relevant line functions
- Drives trial startup by coordinating preparation of FPP by respective CTT LF members,

acceptance by COs, and tracking progress of SSU milestones (RIS, SIVs, FPFVs) in
alignment with CTT, regions, and COs
- Is accountable for recruitment activities as per targets and reviews enrolment at the trial

level, including responsibility for approval of changing recruitment commitment. Is
responsible for forecasting, setting up contingency planning to ensure recruitment
targets are achieved in accordance with trial execution plan, including communication
of timelines for major milestone deliverables from start to end of enrollment, in
coordination with CTT, regions and COs (with Clinical Study Managers)
- Coordinates clinical data collection as per plan, including contingency planning and

communication of timelines for major database lock milestone deliverables, in
coordination with the Data Review Team, regions, and COs
Delivery of quality data and compliance to quality standards
- Evaluates potential challenges/risks within the protocol and operational aspects of the

study in line with the prevailing legislation, GCP, Ethical Committee, and SOP
requirements; assessing impacts, developing risk management plans and
communicating/escalating to appropriate stakeholder
- Works as needed with local teams (Clinical Study Managers, Country Heads, )

Monitoring Excellence group to address clinical data trends that may indicate issues
with quality in trial execution
- Supports inspection readiness and submission preparation for monitoring related

activities

Minimum requirements:

- College or university degree with significant life science experience
- Desired: Advanced degree, preferably in life sciences
- At least 5 to 8 years' experience in clinical research, in planning/executing and/or monitoring clinical trials
- Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
- Demonstrated ability to collaborate across partner functions in a Matrix environment, without direct reports, but can coordinate the activities of others
- Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
- Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
- Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations, and clinical development process
- Understand and apply medical and business knowledge to clinical trial execution
- Excellent negotiation and conflict resolution skills
- Demonstrated ability to influence without direct authority
- Strong interpersonal skills
- Excellent organizational, interpersonal skills with extensive networking expected
- Communicates effectively with senior leaders in a local/regional/global matrixed environment

Is it you who we're looking for? Great! Don't hesitate to sending us your updates CV.
We're looking forward to getting to know you.