Clinical Trial Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Assess project scope and resource allocation regarding Clinical Monitoring

• Strategize and execute clinical monitoring components of projects

• Establish and enforce project-specific functional standards, objectives, expectations, KPIs, KRIs, QTLs, and metrics

• Act as the primary liaison for Clinical Monitoring aspects of assigned projects

• Champion the Clinical Monitoring team with clients

• Coordinate and supervise the daily activities of CRAs and in-house staff

• Ensure that designated CRAs undergo therapeutic and project-specific training

• Create tools and training materials for CRAs

• Organize and facilitate CRA meetings and conference calls

• Monitor study-related information concerning Clinical Monitoring deliverables

• Supervise clinical monitoring metrics, visit reports, action items, query resolution, and quality metrics

• Manage the review and approval of visit reports, site issue escalation, and resolution

• Oversee clinical monitoring milestones and rectify any deficiencies

• Ensure the quality and timeliness of clinical data in the eDC

• Maintain core clinical sections of the Trial Master File in accordance with SOPs

• Engage in clinical monitoring risk planning, assessment, mitigation, issue escalation, and resolution

• Ensure the completion of clinical monitoring and site management closeout activities

• Mentor CRAs and provide constructive performance feedback

• Serve as a trainer/mentor for CRAs and accompany them on field training, assessment, oversight, or co-monitoring visits

• Foster cross-functional relationships with both internal and external team members

• Undertake specific CPM responsibilities as outlined by the Line Manager

• Manage CRA timesheets and escalate any budget discrepancies

• Act as a resource for investigative sites

• Conduct on-site or remote monitoring activities, including pre-study and site initiation visits

• Serve as the primary monitoring liaison for sponsors and sites on smaller or single-service projects

• Take part in bid defense planning and meetings

• Execute other assigned duties

⛳️ Requirements

• Minimum of 8 years as a CRA or relevant clinical research experience

• Prior proven experience as a Lead CRA for at least 1 year

• Successfully maintained fully performing or exceeds-level KPIs and metrics for a minimum of 2 years

• Proven track record of successful Senior CRA performance

• At least 4 of the required 8 years as a CRA monitoring complex studies

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

• Experience in conducting clinical research studies in a hospital environment, pharmaceutical company, or CRO

• Proficiency in English

🏝️ Benefits

• Structured mentoring program

• Leadership development courses

• Dedicated training department

• Ongoing education support

• Hybrid work opportunities

• CTI Cares community and global volunteering opportunities

• Work contributing to life-changing treatments for patients with chronic and critical illnesses