Clinical Data Senior Manager / Associate Director

Rockville, MD

 

RemeGen Biosciences Inc. is a clinical-stage biotech company with multiple pipelines of biologics for the treatment of oncology and autoimmune diseases. 

The candidate is responsible for developing and implementing the strategic vision for the DM group and overseeing all DM activities from study start-up through close-up, reporting, and archiving to accelerate corporate drug development and optimize drug lifecycle management. The candidate will oversee all DM workstreams to ensure highest standard in data integrity and quality of clinical data to meet the requirements for global drug registrations. 

Responsibilities：

  • Responsible for formulating CDM strategy, operations, and infrastructure. Establish a process to ensure data integrity, high quality, and regulatory compliance

  • Ensure that the data management plans (DMPs) in the clinical research and planning is consistent and compliant

  • Provide supervision and guidance to CROs to ensure timely delivery and compliance with regulations of outsourced activities. Oversee CROs data management function inspections and audits as needed

  • Responsible for ensuring that the data collected in the clinical database by vendors meet the requirement of research objectives and quality standard 

  • Provide leadership and direction for CDM team and outsourced activities

  • Manage and train CDM team to coordinate ongoing data management reviews, create reports/specifications, and update CDM plans

  • Responsible for all aspects of the CDM process from research start-up to the database lock for the EDC

  • Review and maintain research databases and other related data management procedures and application documents

  • Evaluate research data to comply with the plans

  • Review vendor invoices

  • Ensure compliance with SOPs, GCP, ICH guideline global drug registration standards

  • Lead development and implementation of DM SOPs, work instructions, and DM standards

Qualifications：

  • Bachelor’s degree (or equivalent) in a scientific or health-related field with 7 years of experience in clinical data management in a CRO, pharmaceutical, or biotech environment, including 3 years of experiences in leading the DM project

  • Experience with clinical data collection, cleaning and analysis

  • Skills in team leadership and building positive business partner relationship

  • Solid knowledge of industry and regulatory guidelines such as ICH, GCP, CFR, CDISC

  • Excellent communication, interpersonal and teamwork skills

  • Experience with clinical trials in Oncology preferred

  • Experience in CRO and Vendor oversight in fully outsourced models

  • Strong ability to work across multiple organizations