Project Manager Clinical Cover Letter

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

In my previous role, I was responsible for study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel.

Please consider my qualifications and experience:

• Knowledge of accepted project management standards and tools
• Knowledge of Good Clinical Practice (GCPs), ICH Guidelines, and local regulations, research process and scientific knowledge as relates to clinical trial conduct
• Serves as a licensed clinician with technical or functional expertise supporting clients
• Detailed knowledge of financial control procedures
• Working knowledge of time and cost estimate development
• Experience in the managment of both healthy volunteer and patient studies in Early Phase clinical trials (Phase I, Ib and IIa)
• Detailed knowledge of project, portfolio, and resource management for medical affairs highly preferred
• Project Management Professional (PMP) certification and MS Project experience desirable

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

Previously, I was responsible for oversight and manage performance of Contract Research Organizations (CRO) or other external vendors involved in assigned clinical trials.

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

• Knowledge in documenting all phases of the software development life cycle phases, including but not limited to technical specifications, feasibility studies, configuration, risk assessments/hazard analysis, standard operating procedures
• Thorough understanding of the oncology arena
• Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas
• Understands interplay/intricacies of drug development program
• Understands how studies fit together and planning involved (sees the big picture)
• Maintains scientific knowledge and expertise of indication/asset to possess credibility to discuss with higher level management
• Broad experience in a Clinical Trial Execution discipline
• In-depth knowledge of ICH GCP, FDA regulations (medical device preferred)

Please consider me for the project manager clinical opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for support to clinical research project manager and PI by reviewing study budgets, industry proposals, and federal grants.

Please consider my experience and qualifications for this position:

• Proven Leadership in an Information Technology environment
• Vision, understanding of healthcare trends and technology impacts
• Provides collaborative leadership and management oversight and coordination of research projects and other initiatives
• Anticipates obstacles and implements solutions
• Designs and writes request for proposals, portions of abstracts, presentations and manuscripts, participates in development of SOPs, INDs, Clinical Study Reports and other clinical, regulatory and safety documents
• Ensures appropriate communication plans are in place to facilitate and maintain communication among scientific, regulatory, safety, monitoring, laboratory, and subcontracts project team members and lead interactions with CROs and other vendors with domestic and international site staff
• Participates in budget development and oversight, cost estimating and forecasting review and recommends resource changes based on identified gaps and evolving project needs
• Monitors study accrual and assists to identify strategies to increase enrollment

Please consider me for the project manager clinical opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for guidance and training to Leukemia clinical research team: research nurses, clinical studies coordinators, and data management group in research study’s objectives, overall design, and specimen processing techniques.

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

• Experience with Federal Acquisition Regulations (FAR) preferred
• Thorough understanding of cross-functional clinical processes including data management, Biostatistics, medical writing, drug safety, and regulatory affairs
• Global trial experience preferred
• Experience in company sponsored studies is strongly preferred
• Relevant biotech, pharma or device industry experience
• Clinical Operations or Project Management background
• Experience with data management is highly desirable
• Sets and maintains Data related standards

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

In the previous role, I was responsible for support for inspection readiness activities for Children’s Oncology Group (COG) Research Base, industry sponsored trials and other applicable regulatory body audits and/or meetings.

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:

• Oncology/Immunology biologic drug development highly preferred
• Working knowledge of current ICH guidelines
• Manages and coordinates project activities for the Zika Phase IIB clinical study (and others)
• Assists the clinical research teams in the development of protocol specific plans that adhere to the International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), the National Institutes of Health (NIH) Standards of Clinical Research, U.S. and international regulations
• Conducts site management and other meetings
• Ensures protocol compliance with monitoring in accordance with ICH GCP guidelines and regulations
• Reviews site performance metrics and provides input on quality of work
• Ensures site readiness in accordance with site management plan