Senior Director, Data Management

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At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery
  
  

We See You.

Your wellbeing

Your professional worth

Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

The Senior Director, Data Management will be responsible for leading the data management processes for all clinical studies at the Company. This position is reporting into the Head of Biometrics.

Location: Remote

Responsibilities

• Serve as a leader within the Clinical Development and Clinical Operations teams to help ensure that projects are completed on time, within budget, with high quality and status is transparent across the organization through proactive, effective, and timely communication.
• Lead the data management partnership with Clinical Research Organizations (CROs) for all studies at the Company. Conduct oversight of CROs by ensuring data management documents and tasks are completed and delivered in accordance with timelines and data quality standards.
• Act as lead clinical data manager for clinical studies performing all data management related activities.
• Oversee the development of protocols, database design, edit checks, CRF completion guidelines and data management plans and data validation plans.
• Develop and enforce Data Management SOPs ensuring adherence to Good Clinical Practices and regulatory requirements.
• Establish a governance structure with all data management and related vendors including communication and escalation pathways and agreed-upon key performance indicators (KPIs).
• Collaborate with internal and external functions (e.g., CROs, reading centers, software vendors, clinical development partners, etc.) to ensure that project timelines and goals are met effectively and within budget.
• Partner with the Company Consultants to ensure all project specific communication and exchange of information is optimized.
• Attend all study team meetings to provide updates and issue resolution
• Other duties as assigned.
• This job description is subject to change at any time.
  
  

Qualifications

• Vendor management and oversight experience
• Strong technical skills across data platforms
• Experienced in designing clinical trials utilizing CDISC standards (including SDTM and standard terminology)
• Cross collaboration proficiency with other departmental functions within the CRO or at the Company such as Biostatistics, Statistical Programming, and Pharmacovigilance
• Thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data
• Experience in regulatory GCP inspections/audits
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Ability to manage multiple projects in a fast-paced environment
• Creative, capable problem-solver
  
  

Level of Education: Bachelor's Degree; Masters Degree preferred

Number of Years of Experience in the function and in the industry:

• At least ten (10) years of clinical data management experience in industry, with experience across indications and EDC platforms
• At least four years (4) of management experience in a clinical research environment, most of which should be in industry and preferably on the sponsor side of relationships and preferably experience on a marketing application team
  
  

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

• Success begins with our People
• Patients First
• Integrity
• Results-Driven
• Innovation
• Team Focus
• Diversity & Inclusion
  
  

EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.