Alexion Pharmaceuticals Trial Master Files, Lead Process Specialist in Boston, Massachusetts
This position will be based in Boston, MA, and may require up to 20% travel.
The TMF Lead serves in a key role for the execution of TMF Operations processes and strategy. Provides process subject matter expertise and support for TMF creation, maintenance, closure, and transfer per company and/or CRO SOPs and standards.
Leads and supports CRO and partnership migration and integration activities, TMF reporting and compliance. Provides leadership and support for Alexion TMF Operations and partner TMF operations representatives to resolve any issues identified with the TMF services delivered.
Works with study teams and partners to help analyze vendor system and process changes and impact to applicable internal processes. Executes change management oversight to ensure consistent application of revised standards, processes, and systems functionality across study teams.
Job Duties & Responsibilities
Drive TMF portfolio level initiatives (i.e. process change/development) with CRO(s)
Ensure standards of compliance are adhered to across the portfolio and partnerships
Oversight of assigned portfolio TMF related ongoing activities (i.e. TMF QC schedule maintance, TMF storyboard maintenance)
Mentor and provide high-level oversight of junior TMF positions within assigned portfolio
Assist with establishing and maintaining TMF monitoring and reporting
Delivers KPI reports to study team, manages expectations, and tracks ongoing KPI across study team in conjunction with the Clinical Trial Managers and Clinical Project Leads
Support integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices
Assist with CRO eTMF configuration testing as needed
Assists with and deliver TMF process education efforts
Provides process and planning support the CTM and CPLs for TMF related remediation and process execution as needed
Proactively stay current with best practices and recommends application across portfolio to continuously improve TMF operations processes
May lead projects in support of study or portfolio TMF objectives and attend standing cross functional meetings
Train internal/external study team and departments on TMF related expections, tools, processes, etc.
May manage or mentor junior staff members
3-5 years experience with clinical development processesStrong knowledge of Good Document Practice requirements & ALCOAC+ standards
Demonstrated critical thinking capabilities with forward looking perspective and comfort with ambiguity
Strong verbal, written, and organizational skills with a team-oriented approach
Ability to handle multiple projects on a regular basis
Familiarity with MS Office software including: Word, Excel, Outlook, Visio, Project and PowerPoint
3+ year experience with Trial Master File
Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable
Experience with eTMF systems, preferably Veeva
Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired
Demonstrated individual and team leadership skills
Knowledge of TMF Reference model
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.