Support the design, specification, and development of eCRFs, ensuring adherence to Biogen standards throughout.
Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities.
Support the development of Data Management Plan documents that will ensure delivery of accurate, timely, consistent, and high-quality clinical data.
Works with Third Party /External data Vendors to complete the set-up of data import and reconciliation processes.
Perform comprehensive review of all data generated from the clinical study including Third Party/External data, SAE data and local lab data, as applicable.
Oversees quality control procedures.
With guidance from Principal Clinical Data Lead or Manager, effectively manage project timelines and quality.
Provide reports, status updates, feedback and advice to key study stakeholders on the progress of data cleaning and risk identification/mitigation activities.
Ensures activities that are performed are in with line Biogen’s processes, GCP, Regulatiory Guidelines and Best Practices.
Provide back up support for Principal Clinical Data Lead as required.

Requirements

Bachelor’s degree required, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
4+ years of Clinical Data Management experience required
Ability to work under pressure demonstrating agility through effective and innovative team leadership
Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as elluminate, J-Review, or Business Objects required
Deep understanding of drug development and biopharmaceutical industry required
Strong technical skills, including experience working with using Microsoft Excel functionality
Fluent English (oral and written)
Strong understanding of drug development and biopharmaceutical industry required
High attention to detail including proven ability to manage multiple, competing priorities
Excellent written and oral communication skills

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Clinical Data ManagementData Management PlanQuality Control ProceduresData CleaningData ReviewStatistical AnalysisMicrosoft ExceleCRFsEdit ChecksDiscrepancy Management

Soft Skills

AgilityTeam LeadershipAttention to DetailCommunication SkillsProject ManagementProblem SolvingTime ManagementCollaborationFeedback ProvisionStakeholder Engagement