Clinical Research Manager

Company: Labcorp Drug Development, Labcorp
Location: Durham
Posted on: May 27, 2023

Job Description:

Clinical Research Manager Remote - USA 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. Why settle for one thing when you can have everything? Labcorp Drug Development 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. - Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you. - We are seeking a -Clinical Research Manager to be 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 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. Requirements:
  • 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
  • Minimum of 5-6 years in clinical research in which some experience should be in a CRA capacity.
  • Must have 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 Covid-19 Vaccination Required Pay Range: - - -129K - 165K Benefits: All job offers will be---based on a candidate's skills and prior relevant experience, applicable---degrees/certifications,---as well as internal equity and market data.---Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. - For more detailed information, please click here. - - - #LI - Remote 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. For more information about how we collect and store your personal data, please see ourPrivacy Statement.

Keywords: Labcorp Drug Development, Labcorp, Durham , Clinical Research Manager, Healthcare , Durham, North Carolina