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Clinical Trial Transparency Manager

Artech Information Systems
East Hanover, New Jersey, 07936, United States
January 18, 2019


Job Description:

Job Description:

Job Title: Clinical Trial Transparency Manager

Job ID: BIIBJP00009464

Location: Cambridge, MA

Duration: 12 Month


The Manager (MGR) of Clinical Trial Transparency (CTT) will be an expert on global CTT activities, including protocol registration, tabulated results disclosure, CSR redaction, lay language summaries for patients, EMA policy 0070, and sharing data with researchers. In addition, an understanding of how best to manage patient and HCP questions regarding our clinical trials is important.

The MGR of CTT will have below areas of responsibility:

• As the point of contact for one or more clinical programs, the MGR of CTT will provide ongoing support and subject matter expertise to the clinical development team and/or study team.

• The MGR will execute the strategic plans for Clinical Trial Transparency activities across the product development lifecycle.

• For each assigned program, the MGR will ensure compliance with regulatory/legal requirements and company PhRMA/EFPIA commitments, while confirming that CTT activities support various industry standards (e.g. ICMJE).

• Responsible for providing the program team with visibility into CTT activities via a dashboard (program disclosure plans, compliance metrics, key performance and quality indicators). The MGR will work closely with CTT’s Manager of Business Operations and the CTT vendor to ensure oversight for their assigned programs.

• The MGR of CTT will drive one or more key initiatives, by leading and/or supporting one or more projects. Projects will involve global cross-functional teams, focusing on implementation of new requirements (e.g. new transparency aspects within the EU Clinical Trial Regulation) or process improvement projects that optimize procedures, address quality issues, improve performance, simplify communications, and/or reduce variations.

• The individual will work with the CTT Department Head to develop project plans, identify stakeholders, drive innovation, and deliver project results.

• The MGR of CTT will work closely with CTT’s Manager of Business Operations to ensure that impact to the current operating model (people, process, technology) is adequately assessed and that implementation plans include modifications as needed.

As an expert in CTT, the MGR must remain informed of the external drivers (regulatory/legal requirements, trade association principles, industry benchmarking, standards development, etc.), as well as internal activities, that impact our policy and processes. The MGR may be assigned one or more areas where they will lead and/or support efforts to assess new requirements, develop communication materials, implement change management, and monitor compliance.

Experience required:

• Bachelor’s Degree

• Must be knowledgeable in Clinical Trial Transparency requirements and have experience applying this expertise to strategy and operations.

• Strong understanding of the clinical development life cycle.

• 8+ years in industry, working in one or more of the following functions supporting the execution of clinical trials: clinical operations, clinical development, medical writing, statistics, regulatory, safety, quality.

• Experience leading global cross-functional projects.