Summary: The Clinical Data Manager (CDM), under the direction of the Director, Clinical Data Management, is responsible for the daily clinical data management operations of studies managed by ProSciento. The Clinical Data Manager will concentrate on good data management documentation practices and apply ProSciento procedures to provide excellent service to our sponsors. Higher level CDMs will also mentor lower level staff. Performs duties in accordance with company’s values, policies, and procedures.
Essential Duties and Responsibilities will include the following. Other duties may be assigned at the company’s sole discretion.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
CDM Education and Experience:
Bachelor’s degree in life sciences or mathematics and/or formal or on-the-job training in clinical trial methodology and Good Clinical Practice (GCP) plus three or more years of experience in direct data management experience at a CRO, pharmaceutical, or biotechnology company and/or an equivalent combination of education and experience. Experience writing data entry and training documentation.
Skills, Knowledge, and Abilities:
Technical competency using data management systems, especially EDC systems. Understanding of US and international regulatory mandates and guidance for clinical research including FDA/ICH-GCP. Demonstrated ability to manage a complex workload and prioritize tasks based on program goals. Ability to work quickly and independently and as a strong team player.
Certificates and Licenses:
Certificate in building EDC systems preferred.
Ability to read and interpret documents such as SOP’s, WI’s, procedural manuals, governmental and clinical regulations, and similar documents. Excellent oral, written and interpersonal communication skills with the ability to communicate effectively to employees and Management groups and in group meeting settings.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Computer Skills: To perform this job successfully, an individual should have intermediate knowledge of the current MS Office Suite.
The work environment characteristics described here are representative of those an employee may encounter while performing the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet to moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close, distance and peripheral vision as well as depth perception and the ability to adjust focus. While performing the duties of this job the employee is regularly required to sit, talk and hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk, stoop, kneel, crouch, or crawl.