PPD Principal Clinical Data Manager in Morrisville, North Carolina

The objective of a Principal Clinical Data Manager (PCDM) is to act as a lead data manager for one or more projects. PCDMs will independently lead multiple, high volume and extremely complex studies within a development program.

PCDMs independently lead and/or efficiently perform, with quality, all data management activities within an assigned study. He/she will mentor junior level staff and peers on all associated tasks within a study or program. A PCDM may be responsible for customer contact, functional, administrative and financial oversight of projects assigned. He/she will participate in the development and implementation of processes, procedures and training for the data management function.

PCDMs may participate in business development activities as required and may assign, review and check the work of others performing similar duties.

Education and Experience:

  • Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)

  • Minimum of 5 years of data management experience

  • In some cases, a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily

Knowledge, Skills and Abilities:

  • Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global Standard Operating Procedures and client expectations

  • Strong attention to detail and skill with numbers

  • Ability to use interactive computer programs

  • Strong written and verbal communication skills

  • Strong organizational skills

  • Strong analytical/problem-solving skills

  • Ability to recognize, evaluate and develop plans to mitigate project related risk

  • Ability to work productively with minimal supervision

  • Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data

  • Ability to attain, maintain and apply a strong working knowledge of Good Clinical Practices and applicable Standard Operating Procedures

  • Strong customer focus and excellent interpersonal skills

  • Proven flexibility and adaptability

  • Ability to work in a team environment and independently as needed

  • Ability to act as a study or department expert for DM processes

  • Ability to train and direct a study team

  • Ability to provide leadership and direction to both subordinates and peers

  • Ability to forecast project labor needed

  • Ability to supervise and delegate tasks

  • Must demonstrate excellent judgment in making decisions

  • Ability to travel to other locations as required or as business need dictates

  • Must be able to set and meet, for self and team, timelines or be able to recognize and schedule changes in response to project demands

  • Ability to identify potential out of scope activities to project and CDM management and participate in the contract modification process

  • Strong command of English language and grammar

  • Ability to successfully apply above skills, knowledge and abilities across a portfolio of studies or with a franchise client

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.

*Job: Data Management

*Organization: Clin Dev-United States (CLDUS)

*Title: Principal Clinical Data Manager

*Location: North Carolina-Morrisville - Home Based

*Requisition ID: 144624