Study Manager Cover Letter

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

In my previous role, I was responsible for execution support for proper adherence to regulatory requirements from US and International regulatory bodies for large , Broker-Dealers and Investment Management entities.

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

• Excellent Interpersonal, organisational, and supervisory skills
• Demonstrates a high level of core and technical competencies through management of various components of clinical trials
• Possesses good communication skills and demonstrated leadership abilities
• Preferred exposure in study initiation through study completion in multiple phases of studies (Phase 1-3, 4)
• Extensive knowledge and expertise with specialized dosing route(s) (e.g., inhalation, iv, dermal, ocular)
• Complete both weekly and monthly reports
• Manage the selection and oversight of External Suppliers
• Start up all activities CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight

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

In the previous role, I was responsible for clinical input into clinical studies and initiatives (US, EU and any other territory in which RB operates) through an understanding of clinical study and regulatory requirements and clinical oversight.

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:

• Providing study oversight, leadership and support to Contract Research Organization (CRO) staff
• Oversight of study feasibility, site monitoring performance, preparation of risk Based Monitoring plans, and ensuring eTMF completeness and oversight of all relevant compliance activities for all studies
• Participating in overall Therapeutic Area support together with the therapeutic leads and country experts
• Demonstrated experience in Implementing the studies through the various project stages
• Strategic and forward thinking competencies
• Basic knowledge of epidemiologic or outcomes research
• Highly motivated, able to work independently, raising issues with recommendations for solutions
• Excellent oral (including presentation) and written communication, and computer/database management skills and project management

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

Previously, I was responsible for regulatory Affairs leadership to project teams developing electromechanical devices for pain management (e.g., develop regulatory requirements matrices, creative and compliant regulatory strategies, timelines, and prepare domestic and international submissions).

Please consider my qualifications and experience:

• Good knowledge of ICH GCP, GPP, Roche SOPs/Guidelines and quality standards related to study management
• Clear and accurate communication in written and spoken English
• Previous GLP experience in pharmaceutical or biotechnology industry or equivalent transferable experience
• Solid understanding of drug development, study design, data management systems
• Proficient with MS Office and Acrobat Reader in PC/Mac
• Experience managing Phase 2-4 trials
• Proficiency in Microsoft Word, Excel and Internet navigation application
• Plan and manage highly complex and/or strategic priority clinical studies

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

Previously, I was responsible for execution support for proper adherence to regulatory requirements from US and International regulatory bodies for large Banks, Broker-Dealers and Investment Management entities.

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:

• Identify, implement, lead and manage a cross-functional core Study Team for the duration of the study, working with functional line management to identify team members and resolve issues
• In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through
• College/university education in science or health related disciplines (or equivalent combination of education and experience) is preferred
• Exposure to use of data analysis to support business
• Creativity to see possibilities through understanding of partners’ needs and how data can assist in clear decision-making and actions
• Strong interpersonal, communication and sharp analytical skills
• Oversight for all studies at regional/country level (Global and local studies) in accordance with the overall project plan, and management and maintenance of accurate country/study level plans
• Planning and execution of country study goals and commitments, and ensures compliance to relevant processes

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

Previously, I was responsible for assistance to partners in meeting regulatory requirements within specified deadlines; regulatory requirements will generally be outlined by OSFI and aligned with Basel (Bank of International Settlements) requirements.

Please consider my qualifications and experience:

• Strong understanding of Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations)
• Operations pharmaceutical including direct monitoring and clinical trial/study management experience
• Strong awareness and understanding of cultural differences regional operational differences with demonstrated leadership in project management and vendor management
• Escalates severe deviations to a key parameter
• Ensure set-up, maintenance and Quality Control of the study Trial Master File (TMF)
• Conduct lessons learned at any point in time when requested by management or any Study Team member and mandatory at study closure
• Be the main interface to all cross-functional study team members (data management, statistics, bioanalytics, clinical supplies, insurance group, clinical trial registry )
• Closely interact with the OPL the ECL/CPL to ensure that study achievements are in line with the overall strategy and timeline for the project