Massachusetts Jobs

Principal Clinical Safety Data Manager will lead and implement best practices for safety data handling, integration, reconciliation, and reporting for clinical trials. The role will collaborate cross-functionally and implement clinical data standards for safety information acquisition, processing, and reporting. The position will report to the Director/Associate Director, Clinical Data Management.

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

· Leverage knowledge and expertise to coordinate safety information reconciliation strategy for 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 assess 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.

· Assist in developing and automating a standardized and custom standards library for clinical data review and decision support within studies and across TAs for trend analysis

· 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 eight 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

· 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.

• Expert knowledge of ICH/Regulatory authorities regulations and industry standards applicable to data capture and safety data management process

  · Cross Collaboration proficiency with other functions such as Drug Safety, Biostatistics, Statistical Programming, and Safety and Medical Monitoring

• Outstanding verbal and written communication skills, in addition to excellent organizational skills

• 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

• 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

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.