As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Did you know?
Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.
Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com.
Description of Roles and Responsibilities:
This role is primarily accountable for the end to end performance and project management 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.
For certain studies, the CRM could be responsible 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, policies and procedures, quality standards and adverse event reporting
requirements internally and externally.
o Reviews Monitoring Visits Reports and escalates performance issues and training needs to
CRA manager and/or functional vendor and internal management as needed.
o Performs Quality control visits as required
- Leads local study teams to high performance: trains in the protocol for other local roles, collaborates
with and supports CRAs as protocol expert and coordinates activities across the different local country
roles ensuring a strong collaboration (including the CTC, CRAs, and COM)
- 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)
- Identifies and shares best practices across clinical trials, countries, clusters
- Responsible for collaboration with functional outsourcing vendors, investigators, other external
partners in assigned studies
- Country POC for programmatically outsourced trials for assigned protocols.
- As a customer-facing role, this position will build business relationships and represent MSD with
investigators
- Serves local business needs as applicable in his/her country (If delegated can sign contracts and
manage budgets).
- Supports local and regional strategy development consistent with long-term corporate needs in
conjunction with CRD, TAH and Regional Operations.
- Collaborates internally with HQ functions, regional and local operations, EU Clinical Development,
Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult
with GHH as needed.
- Lead and contribute to initiatives and projects adding value to the business and supporting the strategy
Experience Required
- 5-6 years of experience in clinical research
- CRA experience preferred.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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