Hybrid Data Management Lead - Clinical Trials

SERB Pharmaceuticals; Conshohocken (Montgomery County); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid Working

Vacation, Personal and Sick time

Medical, Dental, Vision and other Vol.

Paid Parental Leave

Tuition Assistance

Discretionary Bonus Plan

Competitive 401(k) with company match

Job summary

SERB Pharmaceuticals in Conshohocken, PA is seeking a Manager, Data Management to lead data management activities for company-sponsored and IIS studies, including protocol review, SAPs, eCRF design, database development oversight, data cleaning, and compliance with ICH-GCP.

This onsite role requires 3 days per week in the Conshohocken office and a strong track record in managing CROs and vendor relationships, with deep knowledge of CDASH, EDC, data quality, and database lock processes.

Qualifications

• 3-5 years of experience in Clinical Data Management within pharma/CRO/related
• Experience managing clinical studies from startup to database lock
• Experience working with EDC systems
• Experience managing outsourced vendors and CROs
• Experience in trials within GCP-regulated environments
• Global clinical trial experience preferred
• CDASH standards and data collection best practices familiarity

Responsibilities

• Manage Data Management aspects of company-sponsored and IIS studies according to SOPs and ensure compliance with internal procedures and external regulations.
• Ensure studies comply with protocol, GCP, and regulatory requirements.
• Lead eCRF design and UAT activities and oversee database development and maintenance through database lock.
• Manage data review, query management, reconciliation, and database lock processes.
• Review SAPs to align with protocol objectives and data collection strategy.
• Supervise outsourced Data Management activities and manage vendor/CRO relationships.
• Prepare Data Management budgets and manage activities within approved budgets.
• Collaborate with Legal, Procurement and study teams on DM contracting and vendor activities.
• Author/review Biometrics and DM SOPs and related docs.
• Align with global DM to standardize processes and best practices.

Skills

Clinical Data Management

EDC systems

Vendor management

CDASH standards

GCP knowledge

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

SERB Pharmaceuticals in Conshohocken, PA is seeking a Manager, Data Management to lead data management activities for company-sponsored and IIS studies, including protocol review, SAPs, eCRF design, database development oversight, data cleaning, and compliance with ICH-GCP.

This onsite role requires 3 days per week in the Conshohocken office and a strong track record in managing CROs and vendor relationships, with deep knowledge of CDASH, EDC, data quality, and database lock processes.