Clinical Trial Manager

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 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 CTM 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

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

Prior proficient performance as CTM 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