Ref #: 39352

Employment type: Permanent - Full-Time

Location: France

Posted: 21-Sep-2022

Description

Responsibilities:

This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The CRM could be responsible for a particular study for several countries in a cluster.
Responsibilities include, but are not limited to:


• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country
commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
• Responsible for creating and executing a local risk management plan for assigned studies
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies
• Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate)
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
• Country POC for programmatically outsourced trials for assigned protocols.
• Serves local business needs as applicable in his/her country(If delegated can sign contracts and manage budgets)
• Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
• As a customer-facing role, this position will build business relationships and represent the client with investigators
• Shares protocol-specific information and best practices across countries\clusters

Qualifications:

• Knowledge in Project/Site Management.
• Strong organizational skills with demonstrated success required.
• Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD
• Requires strong understanding of local regulatory environment
• Strong scientific and clinical research knowledge is required
• Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
• Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
• Proficiency in written and spoken English and French. The incumbent must be competent and effective in written and verbal communication.


Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.