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PPD Data Manager - Central Lab in Highland Heights, Kentucky

Company Overview:

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health!

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

/To learn how PPD can advance your career, apply now!/

Role Summary:

Coordinates all data management project management-related activities, including all aspects necessary for a successful setup, conduct and closeout of assigned studies. Builds strategic partnerships with our clients to ensure future business. Presents requested materials to sponsors. Plans and monitors all activity during the conduct phase of the study, including the training/re-training of support staff on routine reports and transfers, as well as facilitating the cleaning process to ensure a clean database lock period. Proactively leads the closeout/lock of the database 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:

  • Plans and monitors all activity during the conduct phase of the study, including the training/re-training of support staff on routine reports and transfers, as well as facilitating the cleaning process to ensure a clean database lock period. Presents materials to sponsors.

  • Programs and applications and tools to ensure quality output; including but not limited to programming and DSR validation, and data transfer format development.

  • Generates the transfer of data to recipient for all complex and/or milestone transfers; including the scheduling, running, QC, and sending of the file to the sponsor to ensure high quality data transfers.

  • Generates all complex and/or non-routine reports for internal and external customers; including the scheduling, running, QC, and sending of the report to the sponsor to ensure consistent reporting of data.

  • Tracks project performance and current riskprofile via project dashboard.

  • Performs other duties as assigned.

Education and Experience:

  • Bachelor's degree or an equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills and abilities.

  • 2 years prior Data Management experience

  • SQL and SASS programming experience

  • Central lab and or clinical research experience preferred

/Years of experience refers to typical years of related experience needed to gain the required knowledge, skills,and abilities necessary to perform the essential functionsof the job.Years of experience are nottobe used as theonly determining factor in establishing the job classor making employment selection decisions./

Knowledge, Skills and Abilities:

  • Demonstrated ability to work with PM and the Sponsor/recipient to effectively negotiate timelines.

  • Proven track record of customer-driven interaction with external customers, including sponsors, CROs, reference labs, and any other external contact (e.g. EDC vendor).

  • Basic knowledge of reading and interpreting user requirements documents to develop a product (i.e. interpret a Data Transmission Agreement from sponsor/ recipient and create an appropriate format)General programming/logic knowledge

  • Proficiency in MS Office products (particularly Excel)Outstanding oral and written communication SkillsExceptional time management, planning, organizational skills

  • Proven track record of successful risk management techniques and/or the ability to mitigate risks before they become issues.Proficient in presenting materials at industry level

  • Demonstrated ability to work with and motivate othersProven ability to perform multiple tasks effectively in a stressful environment

  • Demonstrated strength in ability to build relationships with diverse groups (e.g. labs, IT, PM, Sponsor/CRO)

  • History of proactively initiating work and self-managing peaks and valleys of a position.

Working Conditions and Environment:

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

  • Occasionally drives to site or client locations, occasionally travels within the United States.

  • 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.

  • Exposureto fluctuating and/or extreme temperatures on rare occasions.

  • May rarely work non-standard hours.Physical Requirements:

  • Frequently stationary 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.

  • Occasional mobility required.

  • Occasional crouching, stooping, 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 moderately complex 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, relates sensitive information to diverse groups.

  • Ability to apply basic principles to solve conceptual issues.

  • 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.

  • Must be able to use personal protective equipment (including but not limited to gowns and gloves) for extended periods of time.

Job: *Data Management

Organization: *US BU

Title: Data Manager - Central Lab

Location: KY-Highland Heights-Highland Heights KY Tesseneer

Requisition ID: 185335

PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group

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