AD Data Management Consultant - Safety at Softworld Inc

Job Title: AD Data Management Consultant - Safety

Job Location: Cambridge MA 02141 (Remote)

Requirements:

• Must have solid technical experience with UAT
• Experience leading team members and embraces change management
• Experience with RSG (Rave Safety Gateway) is a plus

Job Description:

• The client seeks an AD Data Management Consultant - Safety to lead and implement best practices for safety data handling, integration, reconciliation, and reporting for clinical trials.
• This position will manage/lead 2 FSP contractors and will also be hands on and in the weeds on a regular basis.
• The role will collaborate cross-functionally and implement client's clinical data standards for safety information acquisition, processing, and reporting.
• The position will report to the Associate Director, Clinical Data Management, Safety Processes.

Here's What You'll Do:

• Work collaboratively with cross-functional stakeholders, including Drug Safety, Clinical Data Management & Standards, and Digital, to implement best and emerging practices for safety information integration, reconciliation, and processing across all phases and therapeutic areas within client company standards.
• Leverage knowledge and expertise to coordinate safety information reconciliation strategy for client-sponsored clinical studies; oversee the activities of DM vendors ensure deliverables are met following the agreed-upon requirements
• Collaborate with Data Management, Drug Safety, and Digital to support new technologies and innovative solutions in improving the effectiveness, automation, and quality of safety data integration and processing
• Oversee the DM-related preparedness and safety data deliverables across all the portfolio
• Participate in SOP development governing safety data integration, processing, and reconciliation
• Collaborate with clinical study teams and vendors to ensure project deliverables are met, including quality data review and reporting in compliance with GCP, SOPs, and regulatory requirements
• Participate in developing Data Management documentation, including the Data
• Management Plan, Medical Coding Plan, Safety Information Reconciliation Plan, CRF Completion Guidelines, etc.
• Participate in other initiatives as required or delegated

Here's What You'll Bring to the Table:

• Bachelor's Degree in a science-based or health-related field
• At least 8+ years of clinical data management and/or data safety experience in the industry using multiple database management and pharmacovigilance platforms.
• Experience utilizing safety gateway(s) is an asset.
• Experience in specifications development and implementation of Clinical and Safety Data integration projects
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Excellent interpersonal skills, ability to develop essential relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations
• Cross Collaboration proficiency with other functions such as Drug Safety, Biostatistics, Statistical Programming, and Safety and Medical Monitoring
• Demonstrated ability to translate strategy into action; excellent analytical skills, and an ability to communicate complex issues in a simple way and orchestrate plans to resolve issues and mitigate risks
• Medical coding experience in the industry using MedDRA and WHO Drug across multiple indications and coding platforms will be an asset.
• Multi-faceted background devising plans for operational challenges such as preparing data optimized for clinical data review, creating analytical tools report specifications to identify clinical and laboratory data outliers, vendor oversight, protocol deviation management, etc.
• Knowledge of ICH/Regulatory authorities' regulations and industry standards applicable to data capture and safety data management process
• Creative, capable problem-solver