Senior TMF Specialist

Boston, MA
Full Time
Clinical
Mid Level
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview
Rhythm Pharmaceuticals, Inc. is seeking a Senior Trial Master File (TMF) Specialist to join as an integral member of the Clinical operations team, reporting to the Senior Director of Clinical Process and Quality-Control Management, (CPQM). This position will work closely with the Clinical Study Teams in document management and quality control processes, ensuring compliance with regulatory requirements (GCP, E6 ICH Guidelines, relevant regulations, e.g., 21 CFR Parts 312 and 314), EMA Clinical Trials Directives), company Standard Operating Procedures (SOPs) as appropriate, and providing expert guidance to study teams. The Senior TMF Specialist works with cross-functional teams, including Clinical Operations, Quality Assurance, and Regulatory Affairs, to ensure the Clinical Studies TMFs are kept both current and inspection ready. This position will support CPQM in quality control and process improvement activities that relate to TMF documentation.

Responsibilities and Duties
  • Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks.
  • Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with Clinical Project Managers (CPM) and Clinical Trial Associates (CTA) to implement corrective actions and prevent future issues.
  • Lead milestone TMF reviews, ensuring that all required documents are accurately filed and accessible.
  • Support of CPM and CTA with activities related to TMF Migrations.
  • Monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner.
  • Communicate TMF filing status to cross-functional teams to ensure study goals are met.
  • Use data-driven insights to identify areas for improvement.
  • Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency.
  • Ensure the TMF complies with all applicable regulatory requirements and guidelines.
  • Prepare for and support regulatory inspections and audits related to the TMF.
  • Support CPQM to track and evaluate key performance indicators (KPIs) related to TMF quality and compliance while providing strategic recommendations to improve TMF processes.
Qualifications and Skills
  • Bachelor’s Degree Required
  • 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience with global clinical trials is highly desirable
  • Proven ability to successfully oversee TMFs including development of relevant processes and policies
  • TMF Certification or TMF training preferred (e.g., DIA’s TMF Certificate Program or LMK TMF University) or other relevant certifications
  • Demonstrated ability to multitask in a dynamic, high growth environment
  • Strong oral and written communication skills with a high ability to collaborate effectively across the global organization to achieve desired outcomes

Rhythm operates in a hybrid work environment. This role is based out of our corporate office in Boston, Massachusetts. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs.

More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.  Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
 
At Rhythm our core values are:
  • We are committed to advancing scientific understanding to improve patients’ lives
  • We are inspired to tackle tough challenges and have the courage to ask bold questions
  • We are eager to learn and adapt
  • We believe collaboration and ownership are foundational for our success
  • We value the unique contribution each individual brings to furthering our mission
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law. Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.






 
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