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Senior Clinical Data Manager

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

8-10 years in clinical data management for small to midsize pharma/biotech companies, Direct sponsor experience with CRO oversight, Hands-on experience as a Lead DM for Phase II and Phase III studies in the last 3-5 years, Expertise with Medidata RAVE, Strong communication and organizational skills.

Key responsabilities:

Lead DM on studies, oversee CRO, own study lifecycle, standardize data flow process
Manage timelines to ensure timely high-quality work, ensure data quality for milestones and deliverables
Interact with functional teams for quality data management activities

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

Act as the Lead DM on assigned studies, providing oversight of the CRO and owning all aspects of the study lifecycle as it relates to Data Management
Standardizes and manages the clinical data flow process to data delivery for analysis purposes.
Be the main point of contact for the CRO and in house team, communicating and managing timelines effectively ensuring work is completed on time and at high quality
Ensure data quality in support of clinical study data milestones and deliverables.
Interacts and manages relationships with other functional areas to ensure high quality data management activities.

Requirements:

8-10 years working in clinical data management and specific experience working for small to midsize pharma/biotech companies (must have direct sponsor)
Must have experience with outsourced CRO oversight experience
Experience as a Lead DM for Phase II and Phase III studies within the last 3-5 years, with the willingness to work hands-on
Expertise with Medidata RAVE
Strong communication and organization to manage DM timelines, deliverables etc