Clinical Data Manager (Various Levels) - OSG FSP - Contract/Temporary Opportunity

PPD Summit , NJ 07901

Posted 3 weeks ago

Clinical Data Manager- PPD Outsourcing Solutions Group

  • Various Seniority Levels

  • Home-Based/Remote Based Contract/Temp Opportunity

  • Full Time (FTE 1.0)

  • 6 month duration

The PPD flexible staffing program, with our internal PPD Outsourcing Solutions Group (OSG) offers flexible work options where you can be a part of the PPD culture as a contract, temporary worker, consultant worker or freelancer.

Register today to hear more about open or future these opportunities at PPD!

As a Clinical Data Manager, you will act as the lead data manager for one or more projects and serve as a liaison to the Project Manager and /or client as required. In addition, you will lead high volume/highly complex studies and assist with the oversight of project budgets including identification of out of scope work and participation in the Contract Modification process.

Essential Functions:

  • Ensures database accuracy according to departmental operating procedures

  • Performs a QC review of the data and makes corrections to the DM database

  • Develops data validation manual

  • Defines and tests databases and data validation system

  • Represents Data Management in all cross functional meetings relating to the study

  • Reviews data listings for consistency and accuracy of data

  • Develops and maintains data management project documentation files

  • Performs independent reviews of data management deliverables following documented guidelines

  • Acts as an interdepartmental and sponsor liaison for all DM study activities

  • Produces project-specific status reports for management and sponsors

  • Monitors study metrics

  • Analyzes and resolves discrepancies in data validation or other reports


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)

  • 3 years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience or a combination of performance, education and prior directly related experience may be considered

  • 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:

  • Knowledge of Oracle Clinical (preferred)

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

  • Strong attention to detail and skill with numbers

  • Ability to use interactive computer programs

  • Good written and verbal communication skills

  • Good organizational and analytical/problem-solving skills

  • 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 working knowledge of GCPs and applicable SOPs

  • Strong customer focus and excellent interpersonal skills

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

  • Ability to train and direct study team

  • Must demonstrate good judgment in making decisions

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

  • Must be able to set and meet 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 to assist with the contract modification process

  • Strong command of English language and grammar

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

  • 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 for typical working hours

  • Ability to use and learn standard office equipment and technology with proficiency

  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

  • May require travel (Recruiter will provide more details)

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