Clinical Manager

Hiring By - Biostaffic

 BioPharma

Charlotte, North Carolina - United States

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
The Clinical Manager tasks include:
  • Plans , executes, and completes clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and SOPs, within agreed-upon timeframes and budget
  • Provides oversight and project management of clinical studies, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs
  • Manage and facilitate development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Study Plans, Case Report Forms, Source Documents, Monitoring Plans, Data Management Plan, Project Management Plan, etc.)
  • Provide clinical operations oversight in the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites
  • Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Otsuka departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished
  • Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required
  • Participate in forecasting study expenditures and resourcing needs
  • Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast
  • Provide timely communication of any variances in budget forecast to the Clinical Department Head
  • Establish communication flow with CRO and investigative sites to maximize compliance with study protocol
  • Manage recruitment efforts and activities to meet study enrollment goals and timelines
Qualifications/Experience:
  • 8+ years related experience in the pharmaceutical/biotechnology industry, including 2+ years of management experience
  • 3+ years demonstrated work experience of successfully managing clinical trials within the pharmaceutical industry, including CRO and contract vendor management, preferably in the CNS therapeutic area
  • Experience in management of international or global clinical trials is preferred
  • Minimum BA/BS in life sciences or equivalent college program, and/or commensurate experience in the clinical research industry; Master’s Degree preferred
Required Skills Include:
  • Strong project management skills
  • Experience in clinical site monitoring is preferred
  • Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc.
  • Experience in protocol development/writing is preferred
  • Both working and theoretical knowledge of ICH GCP, clinical trials management with exposure to various phases of drug/trial development life cycle preferred (e.g., Phase I-IV, start-up through closeout), scientific methods, research design, regulatory compliance, and clinical data management
  • Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
  • Strong planning and organizational skills with ability to multi-task and plan activities as they relate to the management of clinical trials, ability to problem-solve
  • Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with physicians, outside vendors, consultants, and team members
  • Possess advanced computer skills (Microsoft applications, spreadsheets, etc.)
  • Ability to work effectively within a team matrix as well as independently
Financial management skills as applicable to oversee project expenditures
  • Minimum BA/BS in life sciences or equivalent college program, and/or commensurate experience in the clinical research industry; Master’s Degree preferred
Terms:
  • 12+ month contract
  • Fully Remote
  • Pay Range: 80-90/hr
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Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Charlotte, North Carolina - United States

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 13, 2024
Company Overview
GForce Life Sciences
GForce Life Sciences

Current Openings: 0

- Ranked #8 for Inc. 5000's Fastest Growing Companies of 2018 & #90 in 2019 - Awarded Best Places to Work in IL in 2018, 2019, 2020, 2021 & 2022 - Recognized as a Best Staffing Firm to Work For by Staffing Industry Analysts in 2018 & 2019 - Awarded Best of Staffing - Talent Satisfaction by ClearlyRated in 2019, 2020, 2021 & 2022 GForce Life Sciences matches highly targeted consultants and direct hire candidates to executives' needs. Regulatory pressures, altering market demands and healthcare refinement are changing the landscape of the global life sciences industry. Patients, providers, payers, and regulators are seeking a higher quality of care and better therapeutic benefits, along with reduced costs and enhanced transparency. With a tremendous success rate, GForce Life Sciences has worked with some of the world’s leading pharmaceutical and medical device companies to address these challenges by providing consultants and executive-level candidates to assist our clients in delivering on the promises they have made to their clients (internal and external). GForce recognizes that there is no “one-size-fits-all” approach to achieving growth and battling industry-wide challenges, therefore we begin with your specific needs and work from there to identify the consultant, team or executive that is the best fit. Unlike larger, “factory firms,” our boutique approach allows us to hand-pick and closely monitor the best candidates for your company and projects. Finally, we back our services with the industry’s leading technology infrastructure, assuring agile, transparent, personalized consulting solutions and business reporting intelligence.
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