Senior/Principal Data Manager

Senior/ Principal Data Manager

LOCATION - Onsite in Cambridge, MA

SALARY

$130,000 - $170,000 + benefits package

The Senior Clinical Data Manager provides oversight of program of studies, will provide clinical data management leadership to the study team, and will serve as primary point of contact for internal and external study team members. This role will be embedded at a large global pharma company.

ROLE/DESCRIPTION

• Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
• Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members
• Provides strong quality and project oversight over third party vendor responsible for data management deliverables
• Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
• Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
• Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency , quality and completeness
• Represents DM on cross-functional project teams & submission Teams
• Lead or support the Health Authority inspections and audits
• Provides coaching and quality oversight of junior Data Management Leads
• Vendor management to EDC and CRO
• PHRI & Elluminate platform experience is a PLUS

REQUIREMENTS

• 10+ years experience as a clinical data manager
• 3+ years experience independently leading studies
• Must have technical / hands on experience with database build (ecrf design, edit checks, UAT)
• Strong communication skills
• Must be located in the US

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA, Europe and Asia Pac. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organizations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Liana Nobile by email at lnobile@i-pharmconsulting.com. If this role is not suitable, Liana is also available to discuss other possible positions or answer any general questions regarding your career and the current market.