Clinical Trial Manager

What You'll Do

- Review scope of project and resourcing related to Clinical Monitoring with Clinical Project Management

- Plan, schedule, and implement the clinical monitoring aspects of projects

- Define and implement project-specific functional standards, goals, and expectations with Clinical Monitoring team including KPIs, KRIs, QTLs and additional metrics as agreed upon

- Primary point of contact for Clinical Monitoring aspects of designated projects

- Serve as advocate for the Clinical Monitoring team with the client

- Coordinate and oversee daily operations of Clinical Monitoring team, including CRAs and in-house personnel. Ensure assigned CRAs receive therapeutic and project-specific training

- Develop CRA tools and CRA training materials

- Organize and conduct CRA meetings/calls if in project scope

- Ensure accurate tracking of any relevant study information related to Clinical Monitoring deliverables

- Oversight of key clinical monitoring metrics, including but not limited to: Visits scheduled per CTMP, Monitoring Visit Reports (MVR) and associated correspondence timelines, Action Items (AI), query resolution, and other quality metrics, to ensure they are met and followed-up on as necessary

- Provide oversight of visit report review and approval, including site issue escalation and resolution; may conduct visit report review and approval depending on team structure

- Manage clinical monitoring related project milestones and proactively address deficiencies

- Oversee the quality and timeliness of clinical data in the eDC per Clinical Trial Monitoring Plan

- Oversee the core clinical portions of the Trial Master File and ensure they are up-to-date and maintained in accordance with SOPs

- Active involvement in clinical monitoring risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation, and resolution

- Ensure all clinical monitoring/site management related closeout activities are completed

- Mentor CRAs, as needed, on the Clinical Project team to ensure high performance and productivity

- Provide feedback/information on CRA performance as requested by CRA line managers

- As necessary serve as CRA trainer/mentor and accompany CRAs in the field for training visits, assessment/oversight visits, or co-monitoring visits.

- Develop successful cross-functional relationships with internal and external team members.

- May be required to undertake specific CPM tasks, as agreed with Line Manager

- Ability to understand and oversee CRA timesheets for tracked hours exceeding budgeted hours and escalate to CPM and CRA Line Manager

- May serve as a contact/resource for investigative sites as required

- May conduct on-site or remote monitoring activities as needed, including, but not limited to, Pre-study and Site Initiation Visits during project startup

- May act as the primary monitoring point of contact for sponsors and sites for smaller or single service projects

- Participate in Bid Defense planning and Bid Defense Meetings as requested

- Assist with other duties as assigned

What You'll Bring

- Excellent verbal and written communication skills

- Excellent organizational and time management skills

- Excellent critical thinking and decision-making skills; proactively identify challenges and potential risks

- Excellent collaboration, customer service, and interpersonal skills

- Ability to work independently

- Proficient in use of laptop computer and software systems, including Clinical Trial Management (CTMS), electronic Trial Master File (eTMF), Electronic Data Capture (EDC), Microsoft Excel/PowerPoint/Word, or similar systems

- Ability to understand complex medical terminology and procedures

- Ability to review and explain study budgets to CRA and CMAs

- Ability to monitor complex indications

- Expert knowledge of ICH/GCP and all applicable regulatory requirements

- Ability to mentor and provide constructive feedback to lesser experienced

- At least 8 years as CRA or other experience in clinical research deemed pertinent by hiring manager

- Prior proficient performance as Lead CRA for at least 1 year

- Maintained previous role performance KPIs and metrics at fully performing or exceeds level for at least 2 years

- Demonstrated successful performance at Senior CRA level, with at least 4 of the required 8 years as CRA, of experience monitoring complex studies

- Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources

- Experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO

Why CTI ?

- We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward

- We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department

- We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade

- Our culture is unparalleled – Click here to learn more about “The CTI Way”

- We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “ CTI Cares” program)

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

- We will never communicate with you directly via Microsoft Teams Messaging or text message

- We will never ask for your bank account information at any point during the recruitment process

Equal Opportunity Employer/Veterans/Disabled

Originally posted on Himalayas