Data Manager

This is a fully remote position, open to applicants in Netherlands, +1 more country.

📋 Description

• Design Case Report Forms (eCRF/pCRF)

• Create and sustain study databases

• Oversee data entry, data integrity, and query resolution

• Remain updated on current scientific advancements within the field

• Engage in and facilitate meetings, conference calls, training sessions, and seminars with internal teams and clients

• Formulate and execute strategies for implementing clinical research databases in accordance with ICH, GCP, and CDISC standards

• Develop standard modules for (e)CRF

• Create and update data management SOPs and related workflows

• Manage projects related to data management activities

• Prepare study-specific timelines and schedules in collaboration with relevant departments

• Establish and comply with audit-specific Data Management Plans and associated documentation

• Define, program, and validate completeness and plausibility checks, edit checks, and data transfers

• Conduct data reviews, data cleaning, and query management

• Manage data from third parties and devices

• Code diseases, adverse events, and medications using study-specific systems like WHO Drug Global or MedDRA

• Organize and carry out third-party and SAE reconciliation

⛳️ Requirements

• Bachelor's degree in natural sciences or a related field

• Familiarity with ICH GCP guidelines

• Experience in developing data structures in line with CDISC standards is a plus

• Reliable, well-organized, and goal-oriented individual

• Collaborative team member

• Proficient in English, both written and spoken

🏝️ Benefits

• Full-time employment