Clinical Trial Manager

About Linical Accelovance:

Linical Accelovance is a market-leading, midsized, global Contract Research Organization (CRO) with a significant footprint across North America, Europe and Asia-Pacific. With operations in more than 20 countries, Linical Accelovance is a full-service drug development partner uniquely capable of conducting large-scale, multinational studies while delivering personalized, hands-on service. We are committed to providing clients with innovative, flexible solutions and expediting promising therapies for patients through the drug development lifecycle. We have an exciting opportunity to join our team as a Project Manager. We offer a unique working environment with a global team culture, competitive salary and benefits package.

Position Description:

The Clinical Trial Manager (CTM) is responsible for the management and oversight of assigned duties on studies. Such duties may include: developing project documents and deliverables; effectively communicating with the Project Manager (PM), Client and study team; managing and training CRAs and other study team members; administering and providing oversight of vendor and/or study budgets and time entry; and managing third-party clinical vendors and contract staff. 

Generally, CTM staff functions under the guidance of the Project Manager. However, CTMs may be responsible for managing individual studies based on the scope of work. CTMs may also provide input into new business proposals and participate in bid defense meetings.

Primary Responsibilities:

  • Manages study start-up:
    • Develops the Project Management Plan and provides input into the study timeline
    • Develops the Site Activation Plan and customizes study start-up documents as needed
    • Manages site identification, recruitment, and selection
    • Performs negotiation of site budgets and contracts
    • Oversees initial regulatory document collection and review
    • Authorizes release of Investigational Product
  • Manages project milestones and proactively addresses deficiencies:
    • Holds study team members accountable to the study timelines and Time Entry Guidelines
    • Provides input to the PM in preparation for Monthly Project Reviews
    • Attends and provides information at Client teleconferences/study team meetings
  • Manages CRA performance:
    • Delegates and oversees work for assigned CRAs
    • Develops the Monitoring Plan (MP), tools, and training materials
    • Ensures assigned CRAs receive therapeutic and project-specific training
    • Oversees the study monitoring visit schedule to ensure compliance with the frequency set forth in the MP
    • Assist the Project Manager in projecting CRA staffing needs, and managing CRA staff utilization
    • Reviews and approves visit reports, follow-up letters, expense reports and timesheets within the required timeframes
    • Ensures regulatory documents are filed according to the guidelines in the Trial Master File Plan
    • Performs the periodic TMF QC reviews
    • Schedules and manages CRA project team meetings
    • Performs quality assessment visits as required
    • Performs remote review of clinical data within the EDC system to identify trends in enrollment and data entry issues at sites; proactively interfaces with clinical monitoring team and Client to identify solutions
    • Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of assigned CRAs
    • In the event of a CRA change, ensures a thorough and effective handover, documenting per SOPs
  • Performs Vendor Management:
    • Participates in the identification and selection of clinical vendors
    • Manages the budget negotiation and contracting process for clinical vendors
    • Ensures clinical vendors meet deliverables per timeline and budget
    • Oversees quality of clinical vendor deliverables
  • Ensures Project Compliance:
    • Ensures progression of projects according to internal and Client quality standards to fulfill all federal and local regulations
    • Oversees the regulatory document collection and submission process. Ensures the Trial Master File is complete and audit ready.
  • Manages Project Finances:
    • Assists the PM in review of the study budget and expenses to ensure financial targets are met
    • Reports completion of project deliverables to ensure accurate revenue recognition
    • Reviews vendor invoices for accuracy prior to payment
    • Assists the PM in generating changes in scope and notifying the Client of changes, as needed
  • Other duties as assigned

Required Education/Experience/Certification:

  • Bachelor's Degree in a scientific, healthcare, or related field; or equivalent combination of education and work experience
  • Years and type of experience:
    • Requires a minimum of three years of clinical research experience
    • Previous experience in personnel management preferred
    • Requires previous experience as a CRA, or demonstrated expert knowledge of clinical monitoring
  • Excellent working knowledge of ICH, GCP, and FDA guidelines/regulations
  • Knowledgeable in all aspects of clinical trial conduct, including systems, study financials and procedures
  • Excellent written and verbal communication skills, conflict management, time management, organizational, interpersonal, and problem-solving skills
  • Strong team-building skills and the ability to work successfully in a matrixed team environment
  • Ability to prioritize and manage multiple tasks, and to delegate responsibility as necessary
  • Dedication to quality in all work tasks and deliverables
  • Proficient in MS Project, Outlook, Word, PowerPoint and Excel products

Considerations:

Our employees enjoy a full range of comprehensive benefits to include but are not limited to medical, dental and vision insurance, company paid life insurance, paid holidays, PTO, 401K with employer match, long and short term disability, and long term career growth and development opportunities. If you have the experience required and are looking to join an energetic and collaborative team, please apply directly via our ADP portal.

Linical Accelovance is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Apply Now!