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reference: 51f3937a-fb05-40cc-8c81-53d432c0ecb2

documentId: 59349159

connectionPointId: 3

Titre du poste: PPD - Associate Project Design Manager

Description de l'offre:
www.stepstone.be/vacatures----1721031-inline.html?cid=Partner_VDAB

Independently reviews clinical trial protocols and interprets Central Lab responsibilities based on protocol definitions and budgeted services.

• Supports Project Management in the review of draft laboratory specifications document for consistency with protocol and budgeted requirements; provides feedback to the Project Manager regarding budget and/or protocol discrepancies, system design requirements, and/or concerns.
• Advises Project Manager on procedural and budgetary items and the necessity for change due to database configuration requirements.
• Ensures consistency of database design across sponsors and/or programs.
• Configures Collection Flow Chart (CFC) based on protocol testing requirements, assay volumes, testing location, sample stability, and frequency of testing.  Determines appropriate testing to sample allocation based on testing schedule, processing instructions, sample disposition, and third party lab requirements.
• Configures Kit Specifications based on protocol testing requirements, assay volumes, testing schedule, testing location, sample stability, testing frequency, study population, assay platform, total allowable blood volume, sponsor/program requirements, as well as determining ancillary supply requirements based on matrices, time points, study population, and collection device requirements.
• Configures sample labels based on client needs and collection requirements.
• Attends internal and external meetings and teleconferences; provides Project Manager support during laboratory specifications development discussions with client.
• Works cross-departmentally to ensure study database design meets client needs, as well as internal requirements.
• Seeks input and guidance from technical operations leads and managers when necessary.
• Under general supervision and guidance from Technical Operations leads and managers, builds study database and creates study deliverables within the time lines established by the team and indicated by the contract.
• Supports Project Management group with the development and implementation of study database design modifications.
• Performs database modifications based on client requirements; updates CFC, Kit Specifications, and sample labels, as appropriate, based on database modifications.
• Monitors assignments and adjusts priorities and work schedule to meet deadlines and provide high quality deliverables. 
• Completes additional tasks as needed to support project, client, and departmental objectives.
• Understands and follows department's working practice documents and SOPs, and contributes to their development as needed, as well as understands and follows appropriate corporate SOPs.

Education and Experience:

• Bachelor's degree in computer science, statistics, biostatistics, mathematics, biology or other health related field.
• 0-2 years of experience with data collection or analysis, or working directly or indirectly with relational databases in a clinical research or clinical drug development environment.
• Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.

 

Knowledge, Skills and Abilities:

• Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data.
• Ability to attain, maintain, and apply a wor...

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2152

abstractJV_contact_0:
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requiredEducationLevelCode: 6

requiredYearsOfExperience: 2

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Nom de l'employeur: STEPSTONE NV

employer_website: STEPSTONE NV

source: PARTNER