Job Description

Project Management and Leadership

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

FSP/CRO/Vendor Oversight

May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)

Continuous improvement initiatives

Lead/provide the relevant support and input to continuous improvement activities within clinical data management
Provides support for CAPA implementation as required

Experience and Expertise Required

Bachelor’s degree required with an advanced degree preferred.
At least 5 years of relevant industry experience.
Project management certification (e.g. PMP) is desirable.
Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
Excellent oral and written communication skills
Communicate effectively with senior management and cross-functional teams
Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]

Travel Requirements

5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)