Clinical Trial Manager

613

Workplace Type: On-site

A Clinical Trial Manager (Sr. CTM) is a member of the project team responsible for the execution of the clinical trial(s) at the site level, accountable for development and execution of the Monitoring Plan (MP), site identification and selection, CRA and site training, development of CRA and site materials, trackers, and logs necessary to track and document deliverables. The CTM will review monitoring visit reports and track actual to projected variables and parameters related to CRA & site activities. All activities will be performed in compliance with cGCPs, country specific regulations, ICH Guidelines, and SOPs. The Sr. CTM may support the project manager, as needed, and may mentor CTMs or other members of the clinical operations team.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Plan and manage study startup including site identification, qualification, selection and initiation activities
• Lead Clinical Monitoring activities through site activation, maintenance and study closure
• Develop comprehensive Monitoring Plans (MP) inclusive of but not limited to:
  1. Monitoring standards (During all stages of the trial)
  2. Communication plan
  3. Selection, qualification & training of monitors
  4. Monitoring methods (including monitor and site training)
  5. Investigator Site File oversight
  6. Investigational product management
  7. Source data verification processes
  8. Protocol deviation tracking & resolution
• Develop study specific templates for use by the Clinical Monitoring team (CRAs) and/or sites
• Establish clinical monitoring study milestones and ensure accurate tracking and reporting of study metrics
• Provide study-specific guidance, training, and support for the Clinical Monitoring team
• Prepare weekly study status reports and agendas
• Effectively interact and communicate with clients on a daily basis
• Lead internal and external client meetings
• Ensure that clinical trials are conducted in accordance with country’s regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures
• Conduct monitoring/co-monitoring visits as needed
• Review monitoring visit reports and track report metrics to ensure compliance
• Demonstrate a good understanding of project financials. Provide input to clinical trial budgets and forecast staffing/resourcing plans
• Participate in clinical operations initiatives and programs as assigned
• Prepare and attend bid-defense meetings, kick off meetings, investigator meetings and other study-specific meetings as required
• Conduct Quality Assessment visits with CRAs
• Partner with the project management team and provide back-up and support as needed
• Assist with resolution of CAPAs, as needed.
• Mentor CTMs, CRAs, and other clinical operations staff as needed
• Other duties as assigned

QUALIFICATIONS:

• Education
  1. Minimum requirement of a Bachelor’s degree in biological sciences, healthcare, pharmacy, or nursing; MS/MSc. or PhD preferred
• Training

1. The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:

• Applicable Standard Operating Procedures
• Good Clinical Practices (ICH Guidelines; Good Quality Practices) and local country regulations (as needed)
• 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used In Clinical Trials)
• Good Clinical Data Management Practices
• HIPAA – Protected Health Information/GDPR-General Data Protection Regulation, as applicable
• Drug Development and Regulatory Approval Processes (depending on applicable territory(ies)
• Strong computer acumen in technology applications, including but not limited to, use of eTMF, EDC, CTMS, site EMR systems, etc.

Certification

Member of ACRP/ICR/SoCRA preferred

Experience: 

• 7+ years clinical research experience
• 2+ years of monitoring experience in a CRA or similar role
• 4+ years of Clinical Trial Manager experience (both CRO and industry experience are acceptable), or be able to demonstrate equivalent experience
• Excellent communication and presentation skills
• Excellent interpersonal and organizational skills with attention to detail
• Strong computer proficiency in MS Office including Outlook, Word, Excel, and PowerPoint
• Strong critical thinking, problem solving and analytical skills
• Ability to efficiently organize, multi-task, and prioritize tasks within a multifaceted framework and set deadlines
• Excellent documentation skills
• Ability to maintain excellent working relationships with a broad range of trial staff cross functionally
• Ability to work well in a team environment but also independently without significant oversight; Flexibility in work hours and ability to travel

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.