Confidential · 8 hours ago
Senior Clinical Data Manager
Malvern, PA
Full-time
Onsite
Senior Level, Lead/Staff
$170K/yr - $190K/yr
6+ years expConfidential is a rapidly growing ophthalmology company developing innovative therapies for rare ocular disorders. They are seeking a Senior Clinical Data Manager to provide strategic leadership and oversight of clinical data management activities across multiple programs, ensuring high-quality data collection and compliance with regulatory standards.
Staffing & Recruiting
Hiring Manager
Sayyad Kamarali
Responsibilities
Lead data management activities, ensuring accuracy, consistency, and compliance with regulatory standards
Will be single point of contact for delivery of all data management activities for studies with offshore data managers
Evaluates and provides recommendations for acquiring and implementation of new tools and implements them with minimum disruption to business
Represents Director of data management at cross functional meetings, negotiates data management requirements in line with departmental objectives, Plans, communicates to relevant stakeholders and implements solutions with approval from the Director of data management
Communicates effectively with all levels of the organization and achieves alignment for all stakeholders while delivering data management activities
Advises the Director of data management on all data management challenges, questions with effective solutions
Oversee database build activities, data collection, coding, cleaning, and database lock
Develop and execute data management plans, including risk management strategies
Work closely with internal and external stakeholders, including Biostatistics, Clinical Development, Quality Assurance, and Regulatory Affairs, to facilitate seamless data flow and compliance
Serve as the primary data management contact for assigned therapeutic areas, ensuring proper planning and issue resolution
Ensure timely and quality deliverables within project timelines and budget constraints
Develop and implement validation checks, conduct data reviews, and resolve data discrepancies to maintain high data standards
Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and CDISC standards
Supervise database development, validation, and transfer processes in accordance with SOPs and regulatory requirements
Provide subject matter expertise in clinical data management systems, electronic data capture (EDC) platforms, and data standards such as CDISC
Develop and manage electronic Case Report Forms (eCRFs), data transfer specifications, and validation reports
Establish and refine data management standard operating procedures (SOPs) and best practices
Mentor and train junior data managers, fostering a collaborative environment and continuous learning culture
Ensure direct reports have adequate training and skills to meet regulatory and company standards
Guide teams on clinical data management best practices and evolving industry requirements
Maintain GCP inspection readiness by ensuring proper documentation and compliance with regulatory requirements
Serve as the primary point of contact for data management activities during audits and inspections
Review and approve key project documents, including Data Management Manuals, CRF Completion Guidelines, and validation specifications
Qualification
Required
Bachelor's degree in clinical, biological, or mathematical sciences, nursing, or a related field
Minimum of 6+ years of clinical data management experience in pharmaceutical development or CRO environment
Extensive experience with clinical trials, EDC databases, IRT systems, and diary applications for data collection
Strong knowledge of GCP, ICH, FDA, and CDISC regulatory requirements governing clinical studies
Proven ability to develop SOPs, risk management strategies, and data management plans
Demonstrated leadership, problem-solving, and project management skills
Excellent organizational, communication, and collaboration skills with a team-oriented approach
Self-motivated with a commitment to high-quality, on-time deliverables
Benefits
15% target bonus
Company
Confidential
Centralizing All Types Of Next Opportunities For You In One Place.
Vancouver, US
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase