Associate Director, Clinical Documentation
The Associate Director, Clinical Documentation is accountable for leading large-scale process and technology initiatives with authority to make key decisions relating to overall Trial Master File (TMF) policy, standards and inspection readiness strategy, and is responsible for managing the team of TMF Associates and Coordinators
-Understands comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical development operations to support clinical trials/TMF management.
-Demonstrated advanced project management and effective oversight of multiple projects/priorities and budgets.
-Proven ability to lead multifunctional teams, and mentor junior staff.
-Experience with vendor oversight and managing external partnerships and relationships.
-At organizational level, provides strategic input and guidance, internally and externally as appropriate, to ensure feasible and effective TMF policy and standards.
-Single point of accountability for TMF quality, compliance, and inspection readiness and retains decision-making authority for all TMF related policies, standards, process and infrastructure.
-Assesses the impact of current business, legal, compliance and operational issues/decisions relating to regulatory documents.
-Oversees the creation, maintenance and revision of the official Vertex TMF Content Model and approves change or additions.
-Leads, monitors, and manages enterprise TMF performance to drive quality and compliance across the organization.
-Ensures appropriate identification and mitigation of risks and opportunities/links between projects to ensure integrity of TMF standards and to maintain TMF progress.
-Oversight of Vertex TMF vendor(s).
-Confirms alignment with broader Clinical Operations strategic initiatives and overall Vertex business needs.
-Develops detailed timelines for deliverables, reviewing with appropriate stakeholders
-Facilitates deliverable work streams and tracks progress against timeline, resource, and quality objectives
-Serves as a Business Lead (Subject Matter Expert) for technology initiatives pertaining to clinical documentation and associated information
-Able to manage multiple projects simultaneously
-Mentors and manages mid-level and junior staff, providing input to development plans and performance reviews
- M.S. 4+ years of work experience, or B.S. and 6+ years of Clinical Documentation experience. Work experience in Clinical Research required.
-Strong leadership, decision-making, and negotiation skills required
-Strong interpersonal skills
-Excellent verbal, written, and presentation skills.
-Experience with MS Excel, MS Project, MS PowerPoint, MS Word, eRoom, Please Review, OmniRim, vDocc/Velocity, Other EDMS technology
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.
Vertex 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. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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