Clinical Trials Manager Cover Letter

I submit this application to express my sincere interest in the clinical trials manager position.

In my previous role, I was responsible for expert CQA advice to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Reduce the incidence of cancer
• Increase the survival rate for people with cancer
• Improve the quality of life of people living with cancer
• Provide a source of expertise on cancer control for the government, health service providers, medical researchers and the general community
• Quality Assurance and Quality Improvement training
• Familiarity with GCP, ICH and CFR regulations
• Awareness of the practical application of these GCP regulations/guidelines
• Strong knowledge and experience with MS Word, Excel, PowerPoint & Outlook

I submit this application to express my sincere interest in the clinical trials manager position.

In my previous role, I was responsible for training and coaching to the team including ICH-GCP, SOP and interpretation to local regulations.

Please consider my experience and qualifications for this position:

• Clear written and verbal expression of ideas, an proactive communicator
• Experience in CNS and / or oncology is preferred
• BA/BS/MS in a scientific discipline
• Supervises/manages the User Support team, including a Database Programmer, Clinical Trials Administrators and Help Desk Specialist
• Ensures staff are trained on daily tasks and performs on schedule with complete accuracy
• Manages internal and external user communications for the Clinical Trials Reporting Program (CTRP)
• Oversees the issue tracking system, Enterprise Wizard (EW) for user communications (inquiries, issues, submitted by the internal and external CTRP user community) and CTRP system enhancement requests
• Oversees the training of CTRP Registration and Accrual applications for new/existing CTRP customers

I would like to submit my application for the clinical trials manager opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for qA oversight for Pre-clinical and Clinical Operations (CRO audits, Clinical Site selection, GCP compliance, protocol/report review, etc.).

Please consider my experience and qualifications for this position:

• Experience as a lead or senior research or regulatory coordinator with supervisory experience
• BS in science related field
• Knowledge of Good Clinical Practices, Good Manufacturing Practices, clinical research, clinical trial process and related regulatory requirements and terminology, along with knowledge of clinical database applications such as EDC and CTMS (Clinical Trial Master File)
• Knowledge of the nature of the research done with scientific, medical, and regulatory expertise with experience in project coordination
• Manage clinical pharmacology studies (US and ex-US) and individual study teams
• Track progress of assigned studies/programs and report updates to management
• Review study budgets, contracts, and work orders
• Evaluate external vendors and potential clinical sites for various clinical pharmacology studies

I am excited to be applying for the position of clinical trials manager. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for laboratory & technical support for Clinical Pharmacology Studies in accordance with agreed protocols, and the principles of International Conference on Harmonisation Good Clinical Practice (ICH GCP), and where required to comply with the principles of GLP.

Please consider my qualifications and experience:

• Participate in departmental and company-run initiatives to support continuous business improvements
• Author and review abstracts/manuscripts, , for presentation/publication at internal/external meetings
• Technical proficiency with computer applications such as Microsoft Excel, PowerPoint and SAP business systems
• Previous CRO/Vendor Management Experience
• Global trial experience
• Phase II-IV experience
• PhD level scientist preferred with life sciences background otherwise PharmD, MSc or BSc in life sciences
• Track record of successfully managing multiple concurrent phase I and IIa, multi-country, multi-site clinical trials

In response to your job posting for clinical trials manager, I am including this letter and my resume for your review.

In my previous role, I was responsible for high level FDA, EMA, and ICH guidance and other regulatory expertise to support project teams in maintaining required compliance and to provide awareness and preparation for agency inspections.

My experience is an excellent fit for the list of requirements in this job:

• Oversees the management the NCI ClinicalTrials.gov Protocol Registration and Results System (PRS) account for NCI Sponsored trials registered in CTRP
• Manages compliance with ClinicalTrials.gov results reporting for NCI sponsored trials
• Suggests new workflows to meet changing business needs, collaborating with developers to identify, track, and test system improvements and/or fixes
• Implements quality assurance processes within the team to identify data quality issues
• Coordinates with the database programmer to understand the CTRP database and CTRP data warehouse to perform data queries for internal and external CTRP users
• Works closely with the Associate Director, Clinical Trials Operations to immediately address issues as they arise
• Familiarity with the area of clinical trials, both interventional and non-interventional, in the field of Oncology
• Significant clinical research experience including a high level of awareness and understanding of clinical operations and drug development