Clinical Research Project Manager Cover Letter

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

Previously, I was responsible for guidance based on protocol restrictions and mandates, such as dose reductions and reporting and grading of adverse events.

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

• Experience with laboratory practices for international clinical trials
• Familiarity with pre-analytic, analytic, and post-analytic processes, including both moderate and high complexity testing
• Experience with REDCap, FreezerPro and FreezerWorks
• Experience with international clinical trials specifically in a non-accredited laboratory and/or austere environment
• Experience with a variety of laboratory quality management systems, , CAP, ISO, and CLIA, CLSI
• Demonstrated knowledge in clinical laboratory, processing, storage, and/or shipping of biological specimens
• Knowledge of clinical research operations and data management in a regulated environment
• Investigational Device Exemption (IDE) experience is preferred

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

In the previous role, I was responsible for site management for regulated and unregulated studies to ensure successful conduct of clinical programs, and cross-functional strategies.

Please consider my qualifications and experience:

• Knowledge of clinical trials in medical device or other industry preferred and outcomes research study design
• General knowledge of cardiovascular and/or peripheral vascular disease and therapies
• Follows established SOPs and work instructions
• Experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support
• Working knowledge of clinical research methods and practices for medical devices, including IDE and CE Mark studies
• Working auditing and self-auditing skills
• Working project management and vendor management skills
• Excellent/advanced oral and written communications skills

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

In my previous role, I was responsible for leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval.

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:

• Lead – critical scientific thinking to develop innovative EGS
• Deliver – ensure clinical projects are delivered on time, within budget and in compliance to regulations and SOPs
• Demonstrated experience in clinical trials, neuropsychology, data management or related field
• Experience in clinical research trials and clinical trial protocol development and implementation
• Demonstrated success and skill at researching, analyzing, and evaluating information for preparation of clinical research protocols
• Proven knowledge of databases including design, development, management, and usage
• Experience creating and producing professional published materials such as newsletters, instructional and informative and procedural documents
• In-depth knowledge and understanding of audit requirements involving interpreting regulations, guidelines, and compliance issues

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

Previously, I was responsible for continuous strategic communication designed to update different key stakeholders and senior management on the status of key initiatives, cross-functional prioritization and synchronization of key initiatives.

Please consider my qualifications and experience:

• Strong knowledge / Experience in project management
• Experience in Clinical Research for vaccines
• Technical proficiency with computers and other technology
• Demonstrated knowledge/ background in programming/computer systems
• Scripting languages (Python, csh)
• Thorough knowledge of databases and computer software, including Excel, Access for database functions
• Flexibility combined with excellent interpersonal skills
• Good knowledge of FDA regulations for clinical trials and OUS knowledge is helpful

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

In my previous role, I was responsible for oversight of clinical trials to ensure safety concerns and/or adverse events are identified and appropriate responses are developed and executed.

Please consider my qualifications and experience:

• Proficient computer skills including word processing, spreadsheet generation and database querying and reporting skills
• Demonstrable skills in organizational and project administration skills, tracking study activities for timeliness and completeness
• Direct experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support in vascular devices
• Direct experience in peripheral vascular medical devices, diagnostic and/or interventional clinical trials
• Direct experience in an interventional catheterization lab or endovascular surgery environment
• Extensive experience building reports using Tableau, Cognos, Access, and other similar tools
• Understanding of Net Promoter Score methodologies
• Good knowledge of regulations for clinical trials