Data Manager - Labs

Title: Data Manager - Labs

Division / Dept.: Global Central Lab/ Data Management

Location: Remote/Home Based (United States)

Note: Full time, Permanent, Benefits, 401K

Role Summary: As a Data Manager - Labs you will coordinate all data management project management-related activities, including all aspects necessary for a successful setup, conduct and closeout of assigned studies for PPD's Global Central Lab. You will do this by:

• Building strategic partnerships with our clients to ensure future business. Presents requested materials to sponsors.
• Planing and monitoring 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.

Why PPD? At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer:

• Continued career advancement opportunities
• Complete a 90 day Data Management training program
• Work with your dedicated mentor and have opportunities to become a mentor
• Create a work schedule that ensures you are meeting your work/ life balance needs with the ability to have flexible work from home schedule

Company Overview: PPD is part of Thermo Fisher Scientific. As the world’s leader in serving science, our professionals develop critical solutions—and build rewarding careers. We offer services and products that help customers around the globe in laboratories and clinics, on production lines and out in the field.

Essential functions of a Data Manager - Labs:

• 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.
• Employees hired in this role may be assigned to a US government contract and if so would be subject to COVID-19 vaccination and reporting requirements.

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.
• Previous writing experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) or equivalent combination of education, training, & experience.
• SQL, Oracle SQL Developer and/ or SAS experience
• Client facing experience preferred
• Data management project management 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 Skills
• Exceptional 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 others
• Proven 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.

Below Is Listed The Working Environment/requirements For This Role

PPD Clinical Research Services values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

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