Director, Clinical Data Management
About AlloVir
AlloVir is a publicly held, high-growth biotechnology company pioneering science in the field of virus-specific T cell (VST) therapies.
We embrace a shared mission to prevent and defeat life-threatening viral disease, champion truth, and challenge the status quo in pursuit of constant improvement.
Our innovative spirit lives beyond the lab, in a world where patients fighting viral infection have access to revolutionary allogeneic cell therapies. A world where everyone has access to a healthy immune system.
Success in this role means partnering across the organization to establish an innovative cell therapy manufacturing supply chain, taking a pro-active approach to identifying and overcoming risks and barriers, and challenging in the pursuit of continuous improvement.
At AlloVir, the expectation is that regardless of title, people are both group leaders and individual contributors. Much like medicine, we believe that this person can both do the work and set the work, working across functions seamlessly, sometimes in the lead position sometimes in support.
The Role:
The Director, Clinical Data Management provides direction, oversight, and coordination of all data management (DM) activities according to quality standards, regulatory requirements in partnership with cross-functional teams from study start-up through archival in support of AlloVir development programs. This position will have strategic responsibility for oversight of Contract Research Organizations (CROs) performing Data Management activities for AlloVir studies. This position will have strategic responsibility for staffing and operational aspects of the data management group and participate in defining a vision for the department which can be integrated into the overall corporate vision. The candidate is expected to develop, articulate, and implement strategies to actualize DM goals.
Responsibilities:
- Oversees DM-related aspects of the program and/or project. Collaborates with the cross functional project team on overall data management strategy for the program and/or projects, assuring overall quality and efficiency
- Establish an end-to-end process for data management for all AlloVir clinical studies. Ensure the process is consistently implemented across all studies for multiple projects and across all CROs and vendors
- Provides proactive, timely communication of project status, data trends and issue resolution with internal team and CROs
- Performs peer reviews of DM study documents or other DM deliverables to assure quality of content and, where appropriate, consistency across a program of studies
- Directs internal teams to ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOP's and work instructions (either by AlloVir or CRO) in compliance with applicable regulations
- Provides coaching and mentoring and performance management for DM to enable successful oversight of CROs and vendors as well as internal data review process
- Establishes goals, expectations, and accountabilities for staff, regularly reviewing DM performance with respect to quality and timeliness standards
- Contributes to the development and delivery of department goals in support of corporate goals
- Comfort representing the Data Management function at cross-functional teams and highly matrixed environments
- Works in collaboration with QA and other functional groups, develops and updates data management standard processes and procedures in accordance with CFR, GCP, ICH Guidelines and GCOMP minimum standards and best practices
- Provides technical direction to facilitate the adoption and use of technologies for DM and trial management, especially in relation to efficient technologies and processes to work with CROs
Qualifications:
- Bachelor’s Degree in a relatable field; Master’s Degree is preferred.
- 18+ years of experience in Data Management in pharmaceutical R&D required, including oversight of studies supported by CROs, data import, data cleaning, and custom report generation. OR - Minimum of 15 years at a CRO working in data management, supporting industry sponsored trials.
- Knowledge of all applicable regulations including CPR, GCP, and ICH Guidelines.
- Minimum of nine years of supervisory/management experience.
- Experience with Regulatory Inspection activities.
- Ability to promote and maintain a positive and professional attitude.
- Ability to motivate and lead a team of varying levels of status & ability.
- Ability to lead process improvement efforts, including interactions with CROs.
- Attentive to details and able to independently resolve a variety of issues without close supervision.
- Proven Organization & Planning skills.
- IT literate and knowledge of Database Review and/or Management Systems (e.g., J-Review, RAVE, Medrio, Clinplus, Omnicomm, MERGE, SAS, Oracle, Clintrials, Oracle Clinical, eDM, etc. – knowledge of all is not necessary).
- Proficient with the application of EDC, IVR, ePRO, and other remote data capture systems in the industry.
- Excellent communication skills - verbal, written & interpersonal.
- Working knowledge of medical terminology and experience with clinical research desired.
- Working knowledge of ICH/GCP and of regulatory obligations of the pharmaceutical industry is essential.
- Ability to articulate clearly and conduct verbal presentations with large and small audiences.
Why join AlloVir?
AlloVir is the global leader in developing novel cell therapies that restore natural immunity against life-threatening viral diseases for immunocompromised patients.
We have an innovative pipeline of allogeneic, off-the-shelf, T-cell therapies that treat and prevent many devastating and life-threatening viral diseases. Our technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy.
As part of the ElevateBio portfolio of companies, you’ll have access to award-winning facilities with centralized cell and gene therapy manufacturing capabilities that help advance the development of our revolutionary therapies for immunocompromised patients.
Join a team committed to scientific excellence, focused on passionate engagement, and united in purpose to treat and defeat viral diseases.
AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.