Clinical Data Manager Specialist Analyst - Biotech Resume Search
Clinical Data Manager Specialist Analyst - Biotech Resume Search
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Clinical Data Manager/Specialist/Analyst Resume


Desired Industry: Biotech SpiderID: 14004
Desired Job Location: San Jose, California Date Posted: 7/18/2007
Type of Position: Full-Time Permanent Availability Date:
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel:
Highest Degree Attained: Masters Willing to Relocate: Yes


Experience:
SUMMARY OF QUALIFICATIONS
Clinical Database Specialist/Manager with the proven ability to combine project and staff management expertise in developing and implementing clinical data management activities. Provide long-term strategic and operational solutions utilizing broad-based competencies the use of SQL and SAS programming languages for querying and statistical analysis. Results-oriented leader possessing exceptional verbal, written, and interpersonal communication skills. Solid track record analyzing data requiring evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Sound knowledge of a variety of alternatives and their impact on their business unit. Creative problem-solver with demonstrated talent for providing critical insight into future trends and capitalizing on the use of technology.

PROFESSIONAL EXPERIENCE

BOSTON SCIENTIFIC (GUIDANT CORP) – Santa Clara, California 2006 – Present
Senior Clinical Database Specialist/Manager Clinical Research
Selected by this medical device company dedicated to improving the quality of patient care and the productivity of health care delivery through the development and advocacy of less invasive medical devices and procedures to be responsible for managing and collaborating with internal and external resources (CROs) to ensure completion of departmental clinical data management activities, which includes providing study requirements specifications, completion of user acceptance testing, edit check specifications, query management and statistical data summary listings and ensuring proper training of clinical site personnel.
• Develop and maintain the data management plan for each trial and update all clinical data management SOPs and DOPs to ensure the highest level of training to current personnel and new hires.
• Responsible for providing technical support in database design, edit/validation checks specifications in PL/SQL and adverse events patient coding.
• Responsible for the development of new data management procedures to ensure compliance with FDA and international regulations.
• Responsible for the design and development of electronic case report forms (eCRF) by applying clinical and scientific expertise and using the EDC Systems and following the company’s CRF guidelines SOP and clinical study protocol review.
• Provide statistical analysis expertise to multiple departments in an effort to ensure excellence in all research endeavors.
• Routinely perform statistical analysis for the clinical research department utilizing SAS.
• Define data points for listings, summary table validation and clean-up by communicating and interacting with various study team members.
• Participate in clinical research reviews (protocols, reports and statistical analysis plans) in conjunction with project managers, clinical scientists and statisticians.
• Track metrics and processes, including monitoring workload, measuring progress and providing high-level support, which ensures major deliverables are met according to study contracts.
• Ensure each clinical study database is validated according to company’s quality system software validation and development process.
• Supervise, train and mentor one CDM staff member, perform annual reviews, make salary adjustment recommendations and hire new employees.


LIFESCAN INC. (JOHNSON & JOHNSON) – Milpitas, California 1994 – 2006

Scientist II Information Solution/Clinical Research 2002 – 2006
Provided effective leadership of clinical data management study sub-teams. Responsible for the design, documentation, testing, implementation and management of clinical data collection, review, clarification and reporting systems for clinical studies. Managed two direct reports.
• Oversaw database development, data entry flow and data clean up process for each assigned study.
• Developed clinical data management validation procedures and new methods of database design which led to an overall streamlining of workload and greater efficiency in the clinical data management system.
• Consistently ensured that procedures, data management plans and study files were prepared, maintained and executed in accordance with LifeScan’s standard operating procedures.
• Provided statistical analysis support for 50% of LifeScan clinical studies
• Supported the development and training of clinical data management and clinical research personnel.
• Collaborated with other staff members within the department in the review and evaluation of process improvements.
• Ensured each clinical study database was validated according to LifeScan’s quality system software validation and development process.
• Systematically supported the design, documentation, testing, implementation, validation and utilization of systems and processes within the Clinical Data Management area.
• Managed relationships with contract research organizations (CROs) and service providers.
• Reviewed protocols, CRF Design, creation of CRF completion guidelines and data entry guidelines, database design, validation check definition, data review, query generation and resolution, DM status reports and adverse events coding and reconciliation.
• Managed queries and resolved discrepancies by checking with data source.
• Developed file/format specifications, program data transfer code, QC and process SAS data transfers.
• Provided training for clinical research associates and other personnel in data entry or other data management tasks.
• Ensured compliance with FDA regulations by developing PL/SQL codes that helped decrease data collection errors and ultimately resulted in study completion prior to deadlines.
• Routinely assisted other departments during periods of workforce shortage by training other personnel in data entry to ensure completion of research endeavors.

Scientist I (Clinical Research Department) 1999 – 2002
Developed, participated in and conducted internal studies for verification and validation of the accuracy and effectiveness of the Lifescan family of products in support of the Food and Drug Administration approval process, as well as for proactive identification of opportunities for departmental process improvements and data control enhancements. Implemented and validated eData Management database system for use in clinical trials.
• Implemented and validated an eData management database system that featured complete compliance with Part 11 FDA regulations for streamlined pursuit of new product market release through conduct of clinical trials.
• Ensured data entry and data clean up is done in a timely manner.
• Generated discrepancy reports and resolved all discrepancies.
• Designed, developed and executed two Clinical trials protocols following FDA regulations and Good Clinical Practices.

Scientist I (Clinical Research Department) - continued
• Collaborated extensively with company statisticians and software quality assurance teams in development of strong data gathering and analysis protocols for application and system validation.
• Recognized as a subject matter expert in several statistical analysis computer applications with selection to train a total of approximately 50 research professionals in their use.
• Leveraged written communication skills while authoring Technical Reports that concisely summarized processes used, data collected and results generated during evaluation testing and clinical trials.


Education:
CALIFORNIA STATE UNIVERSITY AT HAYWARD – Hayward, California Projected December 2007
Master of Science in Biochemistry

UNIVERSITY OF KHARTOUM – Khartoum, Sudan 1989
Bachelor of Science in Chemistry and Zoology


Skills:
Clinical Database Specialist/Manager with the proven ability to combine project and staff management expertise in developing and implementing clinical data management activities. Provide long-term strategic and operational solutions utilizing broad-based competencies the use of SQL and SAS programming languages for querying and statistical analysis. Results-oriented leader possessing exceptional verbal, written, and interpersonal communication skills. Solid track record analyzing data requiring evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Sound knowledge of a variety of alternatives and their impact on their business unit. Creative problem-solver with demonstrated talent for providing critical insight into future trends and capitalizing on the use of technology.


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