Summarized Purpose :
Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs / WPDs, to assess the safety and efficacy of investigational products and / or medical devices.
Essential Functions :
Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required.
Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package.
Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports.
Produces project-specific status reports for CDM management and for clients on a regular basis.
Performs data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations as well as Data Listing reviews.
Education / Experience :
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills & Abilities :
Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
Strong attention to detail and skill with numbers and ability to use interactive computer programs
Good written and verbal communication skills and a strong command of English language and grammar
Good organizational and analytical / problem-solving skills
Ability to work productively with moderate supervision
Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
Strong customer focus and excellent interpersonal skills.
Proven flexibility, adaptability and ability to work in a team environment or independently as needed
Must demonstrate good judgment in making decisions
Knowledge of medical / clinical trial terminology
Understands project protocol and Data Validation Manual
Working Environment :
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. 10-20% annual possible.