Trial Operations Manager

For our client in BASEL we are looking for a TRIAL OPERATIONS MANAGER for a 2-YEARS contract.

JOB TITLE: TRIAL OPERATIONS MANAGER

LOCATION: BASEL

DURATION: ASAP TO 31/10/2020

WORKLOAD: 100%

JOB PURPOSE:

. Under the direction of TOM Development Unit Head, the TOM/Sr TOM is accountable for the oversight and coordination of the global monitoring operational aspects of assigned clinical trials, from start-up to close-out, in collaboration with GCT/ICT/CTTs, regions and countries (COs), in compliance with company processes, GCP, ICH and regulatory requirements
. Scope of activities range from trial start-up to close-out including strategic and operational planning, feasibility assessment, trial allocation, start-up activities coordination, patient recruitment, clinical data collection and delivery of timely, high quality submission data, sites close-out, audit and inspection preparation activities. Contributes to the implementation of the Trial Monitoring strategy in the assigned clinical trials

MUST HAVES:

-Education:

. College or university degree with significant life science experience
. Desired: Advanced degree, preferably in life sciences

-Languages:

. Fluent English (oral and written)

-Experience/Professional requirements:

. 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
. Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations, company standards, and clinical development process

MAJOR ACCOUNTABILITIES

Trial Monitoring strategy

. 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
. 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)

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

* Drives conduct of medical and operational feasibilities and communicates aggregated feedback to clinical teams;
. 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
. Coordinates clinical data collection as per plan

* Ensures timely site close-out activities, in coordination with CTT and COs (with Clinical Study Managers)

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
. Participates and/or leads multidisciplinary taskforces

For further details please contact:
Anna Undas
(see below)