Clinical Research Manager

3 weeks ago

Montréal, Canada Fortrea Full time

Clinical Research Manager

Remote - Montreal, Quebec
- The Clinical Research Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations.

The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during the study. As a customer-facing role, this position will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.

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.

Why settle for one thing when you can have everything? Fortrea gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks - working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.

In this role, you will be responsible for:
- Effectively conducting clinical studies and developing the pipeline, while maintaining local regulatory and compliance requirements in countries- Making decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director or Therapeutic Director.- Building and maintaining professional relationships with investigators and other external stakeholders, with strong communication, educational/pedagogic, diplomatic and empathic skills- Overseeing country commitments, compliance and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously.- Working collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors- Coordinating and aligning the regional and broader organization- Building and maintaining relationships with investigators and other external partners and promote Client’s reputation.- Representing Client in Pharma industry issues and in seeking influence in external R&D environment, in collaboration with CRD- Accountable for performance and compliance with assigned protocols in relation to ICH/GCP and country regulations along with client policies, procedures and adverse event reporting requirements- Proactively driving/tracking execution and performance of deliverables/timelines/results to meet country commitments; collaborating with local clinical operations roles; and forecasting country needs- Overseeing quality and compliance including training. Oversight of CRAs and CTCs including QC visits, Monitoring Visit Reports, escalation of performance issues and training needs; oversees CRMs assigned to client.- Collaborating as the point of contact with outsourcing vendors, investigators, and other external partners; overseeing country and site validations, site selection, and recruitment; and responsible for clients' trial education to site.- Collaborating internally with local PV, Regulatory, GMH/GHH to align key decisions in countries and supporting local/regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties:
- PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%- MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%- QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitorin

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