Job#: 3013947

Job Description:

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients’ digital visions.

Apex has an opportunity for an Director of Data and Biostatistics. For applicants who are interested in this opportunity, send your updated resume to Mike Konjoian, Account Manager, at [email protected].

Here are the details:

Position: Director of Data and Biostatistics

Location: Acton, MA (must be local and available for on-site meetings)

Project Duration: 12 Months w/ potential for extension/conversion

Rate: Negotiable Based on Experience

JOB DESCRIPTION

The Director of Clinical Evaluation and Excellence will provide strategic oversight of clinical research studies globally to ensure regulatory compliance. This role is pivotal in leading global regulatory submissions and safety reporting across pre-market and post-market clinical research studies. This role will also oversee the development of documents to meet EU MDR requirements including clinical evaluation reports and post-market clinical follow up reports, lead internal and external clinical audits, and support the maintenance of the quality management system. The ideal candidate will bring deep expertise in medical device regulations, clinical documentation, and cross-functional leadership to drive excellence and innovation in Clinical Affairs.

Responsibilities:

· Lead clinical development strategies to align with corporate and regulatory goals.

· Oversee design, execution, and reporting of clinical trials (feasibility, pivotal, post-market).

· Develop an in-depth understanding of global regulatory and reporting requirements and ensure compliance with ISO 14155, FDA, EU MDR, and other global standards and regulations.

· Serve as clinical subject matter expert in regulatory interactions and cross-functional forums.

· Prepare and submit documentation to regulatory authorities and IRB/EC.

· Respond to regulatory inquiries and lead cross-functional alignment on response strategies.

· Conduct gap analyses and implement procedural updates based on evolving regulations.

· Oversee reporting for adverse events, protocol deviations, clinical complaints and device deficiencies, and manage safety committees.

· Ensure timely and accurate global safety reporting in compliance with 21 CFR 803, ISO 14155, and MDCG guidance.

· Develop and maintain safety plans and investigator brochures.

· Lead internal audits, CAPA processes, and inspection readiness activities.

· Oversee creation of CERs, CEPs, PMCF plans/reports, and clinical study reports.

· Ensure high-quality documentation for regulatory submissions, publications, and technical presentations.

· Manage and mentor a team of regulatory specialists, clinical writers, quality specialists and safety professionals.

· Foster a culture of compliance, collaboration, and continuous improvement.

· Represent the department in strategic planning and cross-functional initiatives.

Education and Experience:

· Bachelor’s degree in Life Sciences or related field (advanced degree preferred).

· Minimum 10 years of experience in clinical research, regulatory affairs, and quality assurance within the medical device industry.

· Proven leadership in global regulatory strategy and clinical documentation.

· Excellent communication, leadership, and project management skills.

Skills/Competencies:

· Excellent written and effective verbal communication skills.

· Ability to communicate cross-functionally across the organization.

· PC skills; word processing, spreadsheet, database, Internet search and utilization.

· Flexible and able to work in a fast paced environment.

· Team player.

· Ability to organize and judge priorities.

· Excellent ability to generate and maintain accurate records.

· Deep knowledge of FDA, EU MDR, ISO 13485, ISO 14155, ICH GCP, and country-specific regulations.

· Strong analytical, organizational, and communication skills.

· Proficiency in MS Office Suite and clinical documentation platforms.

· RAC certification preferred.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.