Manager, Clinical Operations Cover Letter

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

Previously, I was responsible for gCP expertise (interpretation and guidance) to internal and external customers, proactively maintaining cognizance of current GCP standards.

Please consider my experience and qualifications for this position:

• Extensive experience in ICF negotiations and knowledge of Central and Local IRBs
• Strong negotiation skills excellent influencing, training and mentoring skills both written and verbal
• Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures
• Motivated to be a part of a team that is radically changing the delivery of surgical services across the world
• Skilled at data entry and report creation
• Preferred – Major/Minor in Business Administration
• Preferred – Lean Six Sigma trained, MSN
• Demonstrated leadership skills consistent with organization and management of clinical programs in a large scale health system

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

Previously, I was responsible for guidance and mentoring to DI, its supporting functional groups, Sponsor functions and other colleagues as requested in quality concepts, FDA / GCP compliance.

Please consider my experience and qualifications for this position:

• Broad understanding of surgical instrumentation used in Ophthalmology is preferred
• Broad based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, Regulatory, Project Management, ) is preferred
• Flexibility to provide innovative approaches to support marketing approvals globally is preferred
• Current licensure in Illinois as an RN
• Detailed knowledge of the ethical, legal and logistic requirements of obtaining and processing human blood and tissue samples
• Proven clinical development experience of working in teams running clinical studies (study management), monitoring clinical studies or experience of working in clinical studies at an investigator site
• Good knowledge of BM and PK analytical processes
• Effective communication and negotiation skills in English

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

Previously, I was responsible for technical expertise, interpretation and direction in regards to computer validation, GCP regulations and other quality requirements.

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

• Excellent written and oral communication skills, conflict management, time management and organizational skills
• Skilled knowledge of budget and contract negotiations
• Knowledge of the local ethics, legislation and regulatory environment
• Insight into submission and approval processes
• Understanding of development of local Informed Consent other site ready and ongoing study deliverables
• Country and resolve issues locally
• Strong communication and leadership and negotiation skills excellent influencing and training/mentoring skills, both written and verbal
• Maintain familiarity with relevant clinical literature

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

Previously, I was responsible for compliance support by answering questions or providing advice on GCP, SOPs, regulations and guidelines and bring issues to the attention of CA management team as appropriate.

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:

• Strong people and line management experience of a clinical operations team or group (ideally CRA or Study Start Up) is preferable
• Direct experience with clinical sample management
• Prior process development experience needed
• Familiarity with databases is essential
• Maintain professional demeanor under stressful situations
• Proven record of successfully managing multiple competing priorities
• Self-motivated and a quick learner who’s able to take on tasks with minimal direction
• Knowledge of GCP as it relates to clinical trial management

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

In the previous role, I was responsible for quality leadership and direction to Genentech ED stakeholders on GCP related activities/issues and act as GCP expert/consultant for QCO colleagues.

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:

• Direct experience managing Clinical Research Associates is preferred
• Clinical Laboratory
• Bioanalytical Assay Methods
• Monitoring back-ground strongly preferred
• Manage the relationship with clinical study site staff, including investigators, study coordinators, pharmacists, other relevant functions
• Manage the relationship with business partners such as CROs and other service providers
• Communicate and manage communication internally
• Responsibilities in regard to resourcing, line management, training, functional delivery and input on discussions around quality and operational delivery measurements within the Clinical Operations group at country level