Location: Full-remote
Contract type: Full-time 

Job Overview:

PRINEOS is looking for a Data Management Coordinator to manage, coordinate, and organize the activities of the Data Management staff. The candidate will collaborate with cross-functional teams, including Clinical Operations, Biostatisticians, Medical Affairs, and Project Managers. The candidate should have excellent knowledge of regulations and reference standards, as well as on major medical dictionaries such as MedDRA, WHO-DD, etc.

Key Responsibilities:

• Manage, coordinate, and supervise data management activities on clinical studies and investigations (drugs, nutraceuticals, medical devices, IVDs, etc.);
• Coordinate and supervise the design, configuration, and maintenance of clinical databases and electronic CRF;
• Coordinate and supervise the drafting and review of data management documentation (e.g., Data Management Plan, Data Validation Plan);
• Coordinate and supervise data cleaning and query management activities in compliance with study timelines and quality standards;
• Coordinate and supervise clinical data review and reconciliation activities to ensure data integrity;
• Coordinate and supervise the design and validation of study eCRFs;
• Follow the coding process for adverse events (AEs), medical history terms, and concomitant medications; 
• Coordinate and supervise database closure and data transfer activities;
• Supervise and coordinate activities delegated to external CRF service providers;
• Maintain documentation in compliance with GCP, company procedures, and applicable regulatory requirements;
• Interact with clients, auditors, and competent authorities for the Data Management Unit's activities;
• Collaborate with the Business Development Unit in preparing proposals;
• Participate in client meetings (bid defense, kickoff, etc.) and ensure continuative and proactive collaboration with other business units.

Minimum Requirements:

Scientific degree is preferred (e.g., Biology, Biotechnology, Pharmacy, Statistics, Biomedical Engineering);
10 years of experience as Data Manager; 
Familiarity with Microsoft Office tools (Excel, Word, etc.);
Familiarity with the main EDC systems and the design and validation processes of electronic CRFs;
Strong attention to detail and organizational skills;
Excellent written and spoken English.

Preferred Requirements:

Previous experience in resource management and team coordination;
Knowledge of SAS programming.

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Line Manager: Biostatistics Coordinator

Main tasks and responsibilities:

• Contribute to the design of clinical trials by providing an appropriate statistical methodology
• Participate in the definition of study protocols, concept sheets and abstract
• Perform sample size calculation
• Prepare the Statistical Analysis Plan (SAP)
• Perform statistical analysis
• Review study objectives and endpoints with the team
• Prepare statistical reports and CSR statistical sections 
• Generate and manage randomization lists 

Minimum Requirements:

• At least 2 years of experience as Biostatistician (preferable in a CRO)
• Scientific degree in Statistics
• SAS programming
• Good English written and spoken

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Main tasks and responsibilities (in cooperation with the Head of Quality Management):

• Maintain GCP/ICH and ISO 9001 compliant systems and processes which control the quality of work and clinical trials conducted 
• Write and/or review clinical SOPs and support continuous process improvements
• Manage training of staff on company procedures, GCP regulations, and documentation systems
• Manage induction training for new employees and for scientific consultants
• Qualify critical vendors
• Perform documentation control in the TMF and quality reviews of clinical trial essential documents and associated documentation (including Protocols, Investigator’s Brochure, CRFs, etc.) as appropriate
• Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures, as well as regulatory guidelines
• Report significant clinical quality deficiencies and/or risks to upper management and actively participate in solving the issues
• Perform clinical site GCP auditing activities to ensure that studies are conducted in accordance with protocols, GCP and other applicable regulation
• Participate in Sponsor Audit and Competent Authorities Inspections

Minimum requirements:

• Scientific Degree (ideally Master/ PhD in Biology, Biotechnology, Life Sciences, etc.)
• At least 3 years of experience in Clinical Quality maintenance and oversight 
• A high level of English language, both written and spoken
• Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges
• Preferred: qualified Auditor according to Italian Decree on CRO Minimum Requirements (15.11.2011)

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