Assist with all data management project management-related activities, including all aspects necessary for a successful setup, conduct and closeout of assigned studies. Supports closeout/lock of the study databases by working with internal (IS and PM) and external (recipient/sponsor) clients to coordinate all final lock processes - namely final cleaning, unblinding when applicable, and final lock notification.

Essential Functions

Executes and supports of all study activities including but not limited to study database verification, data transfer program validation, preparation/delivery of the data transmissions, vendor lab result upload, database reconciliation, development and validation customized study reports.

Leads all study database verification activities; including the design, test data generation, execution, and documentation study database verification test plans in a timely manner to ensure a quality study database setup.

Manages all data transfer validation activities; including the review of data transfer specifications, test data generation, and execution of validation test cases to ensure the delivery of an accurate test data transmission in a timely manner.

Prepares and delivers routine and interim/final data

transmissions; including the scheduling, execution, QC, and delivery of the data transmission file to ensure high quality, timely, data transmissions.

Independently assesses custom reporting requirements for both internal and external customers; including the design recommendations, specification, development, validation, and delivery of accurate reports in a timely fashion.

Assists/leads routine data reconciliation activities to ensure the timely delivery of accurate study data.

Knowledge of reading and interpreting user requirements documents to develop a product

Programming/logic knowledge

Proficiency in MS Office products

Effective written and oral communication skills

Strong customer service skills

Time management, planning, and organizational skills

Ability to multi-task

Ability to work in a collaborative team environment, Ability to work in an upright and /or stationary position for 6-8 hours per day.

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.

Occasional mobility needed.

Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

Frequently interacts with others to obtain or relate information to diverse groups.

Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

Regular and consistent attendance.

Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.

Occasional drives to site locations, occasional domestic travel.

Exposure to biological fluids with potential exposure to infectious organisms.

Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.

Personal protective equipment required such as protective eyewear, garments and gloves.

Exposure to fluctuating and/or extreme temperatures on rare occasions.