- 10221 Flamingo St Nw Ÿ Coon Rapids, XXXXXX xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

(Date)

(HR Department

Name of Company/Recruitment Firm

Street Address

City, State, ZIP code

Job Reference Number, if any)

Dear Hiring Manager,

        In response to a job vacancy posting for the position of ________________, I am pleased to tender my application in the sincere hope I can become part of your team. My resum is attached for your review and consideration.

What I offer are my Baccalaureate degree in Business Administration, a previous Associate s degree in Medical Administration, and more than 19 years providing clinical data management, regulatory & protocol compliance management, CDISC/CDASH implementation project management, and data quality management in the healthcare solution industry. I am currently with Medtronic in Arden Hills, XXXXXX as a Principal Clinical Data Manager for the company s Clinical Data Management group. Prior to this, I had a year-long internship with the Boston Scientific as Senior Clinical Data Manager. For more details, please take a moment to go through my resum .

In leveraging my technical and managerial competencies in Database Solutions, I also bring to the table my personal strengths that include a passion for achieving business objectives through efficiency-focused and technology-driven leadership excellence. Along the way, I also offer my business-aware social and interpersonal communication skills that help build relationships with the people I work with, fostering a harmonious collaborative work environment in achieving shared commitments.

I have every confidence that my education, experience, and personal strengths qualify me as a suitable candidate for the vacancy, one who can help achieve your objectives as part of your IT management team. Should you need further clarification, please do not hesitate to reach me through my phone or email address indicated in the heading. An interview with you or your representative would be most welcome. Thank you for considering me, and I look forward to hearing from you soon.

Sincerely,

YYYYYY X. YYYYYY

Attachment: Resum

- 10221 Flamingo St Nw Ÿ Coon Rapids, XXXXXX xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

Data Management (Healthcare Solutions)

Qualifications Profile

    Self-assured and results-driven IT management professional with more than 19 years providing clinical data management, regulatory & protocol compliance management, CDISC/CDASH implementation project management, and data quality management in the healthcare solution industry.

-    Detail-oriented and analytical with critical thinking to interpret clinical data, protocols and complex instructions, while strategizing solutions to address issues in data quality control, relationships, and project management.

-    Strong drive towards process efficiencies in multi-disciplinary coordination, strategic and tactical planning, execution and administration of complex data sets in large clinical projects, while ensuring compliance with government regulations and industry s best-of-breed clinical practices.

    Exceptional people management and interpersonal communication skills that foster confidence, performance excellence, professional relationships, and teamwork synergies across multi-functional engagements.

Professional Experience

    Direct and manage the implementation of company-wide CDISC/DASH conformant standards, leading sustainable IT governance in data management projects for a global leader in medical technology solutions.

    Ensure conformance to CDISC/NIH Controlled Terminology and SDTM datasets, providing staff development support in creating company-wide CDISC training materials, and providing expertise in data management.

    Collaborate with Database Programmer Analysts in developing and executing UAT routines, administering clinical databases, ensuring quality data management processes (data review, query generation/resolution, and status reporting to clinical stakeholders), while developing and executing data quality audits, overseeing CRF/DCF database quality control audit prior to database lock.

    Create and maintain Data Management Plans, including CRF/DCF flow, external data handling, SAE processing, coding, lock procedures, and archival procedures, while maintaining SOPs and Work Instructions.

    Develop standards for data entry and queries to resolve database issues, working with the clinical research associate.

    Process laboratory and reference data from local, central, or external labs according to established guidelines.

    Provide HR administration support, mentoring new and junior clinical data management staff.

    Provided data management support, working with the Clinical Project Manager on CRF design process complying with the company s data form standards as well as CDISC / CDASH protocols, while developing and executing CRF completion and data entry guidelines for several remote sites and clinical research associates.

    Collaborated with the Database Programmer Analysts to configure and maintain clinical databases in accordance with company standards, overseeing UAT efforts, and the development of data QC audit procedures.

    Provided database administration, completing data access and revocation request forms and forwarding them to appropriate database personnel, as well as providing CRF completion guidelines at investigator meetings.

    Ensured quality data management activities, creating and maintaining Data Management Plans CRF/DCF flow, external data handling, SAE processing, coding, lock procedures, and archival standards.

    Generated queries, working with the clinical research associate to resolve database issues.

    Assisted in coding medical data using industry standard dictionaries such as MedDRA, WHO Drug, etc.

    Collaborated with Clinical Data Interchange Standards Consortium team to design and build a CDASH model for device manufacturers.

Education & Credentials

MINNESOTA SCHOOL OF BUSINESS Brooklyn Center, XXXXXX

    B.S. in Business Administration (2009) A.A.S. in Medical Administration (2005)

Technical Skills

    RDBMS Systems/Database Administration Database Programming in RAVE

Professional Training & Certifications

    Certified Clinical Data Manager (CCDM) Good Clinical Practices (GCP) Training & Certification

    Various Workshop and Coursework in Management and Training FDA & IRB Training

Affiliations & Community Involvement

    Volunteer: Church, Sunday School teaching, serving meals to disadvantaged, and supporting local shelters

    Board Member: Organizations that support youth developmental activities

    Volunteer: Advocacies in the creation/update of CDASH standards to include Medical Devices