Clinical Leader Cover Letter

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

Previously, I was responsible for ethical expertise and counsel to Christiana Care Health System on moral frameworks, analysis, ethical decision making, organizational ethics and dispute resolution.

Please consider my experience and qualifications for this position:

• Stays current on clinical research best practices
• Oversees the accuracy and timeliness of CTMS, timeline planning tools and other core systems
• Ensures study adherence to ICH/GCP and SOPs
• Serves as a member of global cross-functional Protocol Execution Team(s) (PETs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the clinical development plan
• Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions
• Partners closely with Clinical Science in designing global clinical trial protocols and provides strategic operational input on protocol feasibility
• Provides input to the study budget and manages assigned vendor budget(s)
• Participates in selection of vendors (participates in the Request for Proposal (RFP) process), on a global scale

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

In my previous role, I was responsible for guidance to team members regarding medical device event reporting requirements as per the applicable local laws and guidelines.

Please consider my experience and qualifications for this position:

• Ideally sound knowledge of the respiratory therapeutic area
• Respiratory clinical trial experience
• Experience of managing advisory boards, preparation of advisory committees and managing publication of clinical trials
• Record of cutting edge research and / or clinically-related science as evidenced by first- or co-authored publications in top-tier journals
• Experience in overseeing laboratory efforts of research associates
• Able to distill complex issues and clearly articulate solutions
• Experience and understanding of diagnostic product development, particularly in Oncology would be an advantage
• RN/BA/BS with relevant clinical development experience

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

In the previous role, I was responsible for data Integrity expertise on GMP computerized systems in order for system owners to ensure overall consistency and compliance to applicable Data Integrity requirements.

Please consider my qualifications and experience:

• Oversees delegated outsourced activities to ensure CRO and vendor delivery against contracted scope of work
• Contributes to global study site selection and management
• Contributes to the development and active management of study-specific patient recruitment strategies through participation in enrollment planning workshops
• Comprehensive and current knowledge in relevant therapeutic or product areas
• Previous experience in the management and co‑ordination of clinical trials is desirable but not essential
• Demonstrable knowledge of all phases of clinical trial management
• SAP experience and familiarity with clinical studies is preferred
• Experience in communicating scientific data (lectures, posters, papers, and other media)

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

In my previous role, I was responsible for guidance to health department staff and Hopkins nursing to ensure program goals, patient care and documentation is performed in accordance with program policies and procedures.

Please consider my qualifications and experience:

• Experience with FDA, EMA or other regulatory inspections of sponsor, investigator sites, or CROs
• Demonstrated skills in self-motivation, taking initiative and working independently
• Strong knowledge on project management (global clinical projects
• Strong knowledge of international good clinical practices (ICH) and understanding of current regulatory requirements (FDA, EMEA) related/ applicable to the conduct of clinical trials, understanding of FDA Compliance Manual & EMA Compliance Manual
• Results driven with attention to detail and quality while overseeing and connecting with contributing stakeholders
• Excellent team leadership, presentation, interpersonal and communication skills (written and verbal)
• Experience with CFDA, MHRA or other health authority GCP inspections
• Direct experience of running clinical trials (industry/hospital environments)

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

Previously, I was responsible for policy recommendations to the Thrift Savings Plan Office of General Counsel and the Federal Retirement Thrift Investment Board (FRTIB) by researching and analyzing federal, state and local regulations when applicable.

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:

• Consult with the Head of the Therapeutic Area (TA) and GPL to execute appropriate communication of medical project and study strategy, study results and clinical project results to internal and external bodies
• Knowledgeable with the processes and principles of program and customer relationship management and business analysis
• Up-to-date knowledge of clinical operations processes and information systems
• Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug development experience
• Previous experience in clinical trial planning and execution
• Knowledgeable with Clinical Operations and Information Systems such as EDC, IxRS, Crystal, FELIx, and Clinical Supply Systems
• Demonstrated leadership and customer relationship management skills
• Highly proficient in Microsoft Suite including Microsoft Project