The Clinical Data Liaison (CDL) is responsible for overseeing study-level Data Management services from clinical study initiation through closure, in accordance with applicable Standard Operating Procedures (SOPs), federal and local regulations, and ICH-GCP guidelines.

The CDL liaises with internal and external stakeholders, including Contract Research Organizations (CROs) and data vendors, ensuring study data integrity and timeliness of key data deliverables.

Your responsibilities:

• Support CRO oversight of all outsourced Data Management activities and deliverables
• Develop/collaborate with internal teams and vendors on all study-level Data Management documents
• Advise study team members, including CRO counterparts, and sites on data capture questions and data-related issues
• Participate in study team meetings (internal and external)
• Coordinate and facilitate internal cross-functional data reviews
• Provide cross-functional collaboration and communications to increase data quality and timely data milestones
• Collaborate on the development and maintenance of dashboards to provide data analytics
• Provide ad hoc data and report requests in connection with normal business operations, audit requests, and legal and regulatory requirements
• Evaluate Data Management key performance indicators and develop action/escalation plans accordingly
• Track Data Management timelines and ensure that all applicable stakeholders are aware and on target for deliverables, including EDC go-live, mid-study system updates, interim data snapshots, and database locks
• Identify and escalate project and quality issues; supports corrective/preventive actions as required
• Participate in the implementation of departmental Objectives and Key Results (OKRs); recommend process improvements and initiatives to enhance operations

Your profile:

• Knowledge of the pharmaceutical/device commercialization process, applicable standards, and regulatory guidelines (ISO, ICH-GCP, MDR etc.)
• Basic understanding of global data operations tasks, specifically within Data Management and database programming and relevant data standards
• Basic understanding of relational databases and data capture standards (e.g. CDASH)
• Computer skills, including proficiency in MS Office (Word, PowerPoint, Outlook, Excel); including with complex pivot tables and data analysis
• Strong organizational and record-keeping skills with strong attention to detail, precision, and accuracy
• Ability to work well in a team as well as independently with limited oversight; is self-motivated and results-driven
• Excellent verbal and written communication skills, providing clear, concise, timely, and relevant information

Benefits:

Financial

• Performance related bonus
• Life Insurance

Lifestyle

• Free fruit & cookies delivered for office staff
• Multisport card

Health

• Private Medical care