The TMF Compliance and Education Lead is an analytics oriented thought leader within the TMF Operations team responsible for overseeing creation and maintenance of sustainable compliance monitoring and reporting plans. This position will coordinate and monitor the creation of Key Performance Indicators (KPI) for review at various levels of the organization and help standardize reporting with partners and Contract Resource Organizations (CRO) to ensure adherence to TMF processes and successful remediation of queries. This person will also utilize a strong knowledge of TMF and Clinical Operations to help create and maintain a sustained approach to TMF Education. This is a key position within Development Operations and Quantitative Sciences (DOQS) Center of Excellence (COE) and involves routine interaction with senior management and external partners
Job Duties & Responsibilities
Lead the creation and maintenance of sustainable TMF compliance monitoring and reporting plans in alignment with overall TMF strategy to ensure quality standars across study life-cycle.
Lead the creation and maintenance of TMF education program components to ensure organizational understanding of TMF operations.
Identify trends across portfolio to help determine effectiveness of TMF processes and requirements
Ensure timely TMF process execution across portfolio escalating
Identify gaps based on data review and proactively propose corrective action(s)
Ensure standards of compliance are adhered to across the portfolio and partnerships
Provide quality oversight of data produced ensuring accuracy of data prior to distribution to teams.
Provide reports to study teams.
Maintain historical data to evaluate continuous improvement efforts.
Responsible for corrective and preventative actions activities and performing effectiveness checks to ensure preventative actions are adhered to and effective.
Will attend cross functional meetings.
May manage or mentor junior staff members.
5 years TMF or clinical research experience.
Demonstrated strategic thinking capabilities with forward looking perspective and comfort with ambiguity.
Demonstrated project management skills.
Strong verbal, written, and organizational skills with a team-oriented approach.
Ability to handle multiple tasks to meet deadlines in a dynamic environment.
High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, Project and PowerPoint.
Strong eTMF experience a plus.
Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable.
Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired
Knowledge of Health Authority regulations, directives, statutory instruments and ICH GCP guidelines.
Boston, MA, United States
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 through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). 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). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. 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, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. 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.
Alexion Pharmaceuticals, Inc.