Data Manager

📋 Description

• Act as the main internal and Sponsor liaison for all inquiries, issues, and escalations pertaining to data management, including data collection, cleaning, delivery, reconciliation, timelines, and database locking.

• Establish, maintain, and communicate the Data Management Plan (DMP) in collaboration with Sponsors and internal Clinical Data Management teams.

• Identify and document both standard and study-specific edit checks, as well as data processing guidelines to ensure the delivery of clean, high-quality data.

• Work together with internal teams on study setup requirements, which include demographics collection and visit schedule specifications.

• Lead the creation, review, and finalization of data transfer requirements, comprising file specifications and necessary approvals.

• Coordinate with SAS Programmers for the generation of data files, development of edit checks, and validation activities.

• Produce and deliver sample, routine, complete, and final data transfers in accordance with study timelines.

• Oversee database lock activities with Sponsors to maintain data integrity and ensure the adherence to deliverable timelines.

• Serve as the primary contact for Data Correction Requests (DCRs) and for the escalation of queries.

• Engage in the review and approval of Data Management components to guarantee high-quality study setups.

• Keep comprehensive and up-to-date Data Management documentation, which includes Data Management Plans, file specifications, data transfer agreements, data correction requests, and communications with Sponsors.

• Recognize out-of-scope requests and escalate them to the Project Manager for Change Order processing.

• Conduct regular status meetings with Sponsors, CROs, and internal teams, including the preparation of agendas and meeting minutes.

• Assist in monthly reporting activities by providing necessary Data Management metrics.

• Ensure high levels of customer satisfaction by fulfilling commitments, timelines, and quality expectations.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences or a related field is preferred.

• A minimum of 2 years of experience in Data Management or a related field, ideally within a clinical research setting.

• Prior experience in a client-facing role is preferred.

• Proficiency in Microsoft Office applications is required.

• Strong skills in organization, time management, interpersonal relations, and problem-solving are essential.

• Capability to handle multiple priorities in a fast-paced, regulated environment is necessary.

• High attention to detail and a strong commitment to data quality are crucial.

• Familiarity with or experience in SAS and/or SQL is advantageous.

• Knowledge of CDISC SDTM standards is a plus.

• Strong written and verbal communication skills in English are required.

🏝️ Benefits

• Competitive compensation.

• Comprehensive health, dental, and vision coverage.

• Retirement savings plan with company contribution.

• Paid time off and company holidays.