FSP Clinical Research Manager

Fortrea•Durham, CA

3d•$135 - $150•Remote

About The Position

FSP Clinical Research Manager – Remote US 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. 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 client's 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.

Requirements

Education: Bachelor’s degree in science or comparable
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
Thorough understanding of the drug development process
Fluent in local office language and in English, both written and verbal
Experience: Minimum of 5-6 years in clinical research in which some experience should be in a CRA capacity.
1+ years of experience as a PM or CTL managing projects.
Must have a strong understanding of local regulatory environment, country regulations, client policies and procedures, quality standards.
Strong scientific and clinical research knowledge is required for this position.
A strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
The role will require proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment.
The position requires strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance.
Good organizational and time management skills
Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
Excellent communication skills, oral and written.
Self-motivation with the ability to work under pressure to meet deadlines.
Works well independently as well as in team environment tail and process oriented.
Positive attitude and approach
Interact with internal and external customers with high degree of professionalism and discretion.
Multi-tasking capability.
Good computer skills with good working knowledge of a range of computer packages
Ability to lead and develop junior staff.
Flexible and adaptable to a developing work environment

Responsibilities

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.
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 client's 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.