Clinical Trials Manager (CTM) I/II
The CTM I/II will serve in a leading role and as the primary operational contact for driving clinical studies with cross-functional teams for the execution of the studies. They will be accountable for supporting and conducting clinical trials; focusing on the areas of trial planning, enrollment, site monitoring, data quality, and study reporting to ensure project milestones deliver on time, within budget, high quality and in compliance with ICH/GCP and all regulatory requirements, SOPs and other quality standards. The individual must have the ability to work independently with minimal supervision and strategic thinking capacity to drive the studies with effective engagement across team members in a fast-paced environment. Strong initiative and follow through are essential for success in this job.
Essential Duties & Responsibilities:
- Implements and manages operational aspects of trial set-up, execution, oversight and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements
- Recognizes cross functional or company-wide impact of problems and considers implications in solution management while serving as an escalation point and resource for internal and external teams to help drive strategy and study initiatives
- Accountable for quality data and meeting timelines and providing guidance to study team as needed
- Participates in protocol, CRF development, Clinical Study Report preparation, as appropriate
- Develops/prepares metrics and updates for management
- Proactively identifies potential study issues/risks and recommends/implements solutions
- Oversees and facilitates CRO/vendor selection process for outsourced activities
- Manages CRO interactions, including sponsor oversight of Clinical Operations functional activities (e.g., study management, monitoring, site management, trial master files)
- Work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
- Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Study Manuals, and CRF Completion Guidelines)
- Reviews site study documents for accuracy and completeness (e.g., protocol, informed consent template, study tools/worksheets, study plans/manuals, monitoring visit reports, data listings, etc.)
- Participates in interim and final report preparation for regulatory submissions
- Reviews/approves vendor invoices and manages accruals and payment process for all clinical vendors including providing input to general study budgets, and identifying opportunities to reduce costs
- Recommends and implements innovative process ideas to impact effective and efficient clinical trials management
- May work with academic sites on Investigator-Sponsored Trials (IST’s) and oversee IP supplies and dispensing and accountability records and safety activities and may run status update TC with the site and PIs.
- Oversees internal or vendor’s clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
- Participates in the development, review and implementation of departmental SOPs and processes
- Participate in financial end of month close meetings with financial analysts.
- May be assigned other projects and duties as required
- BS/ BA or equivalent.
- 2-5 years of global clinical trial (Phase 2 & 3) management experience in the pharmaceutical or biotechnology industry.
- Experience in oncology (preferably solid tumors) highly desired. Experience in immuno-oncology a plus.
- Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
- Strong demonstrated experience in interactions with outside vendors/CROs and management of vendors.
- Previous experience EDC, eTMF and CTMS
- Requires proven project management skills and study leadership ability.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly.
- Must have excellent interpersonal, written and verbal communication skills.
- Knowledge of FDA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials.
- Strong computer experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Teams)
- Able and willing to travel domestically for site visits as applicable
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability