TMF Operations Associate

Job Summary:

The Trial Master File Operations Associate is responsible for the upkeep of Trial Master Files (TMF) for clinical trials, ensuring adherence to regulatory guidelines and industry standards. Individuals in this roll with work cross-functionally to manage, review, and archive documents, ensuring the accuracy and completeness of clinical trial documentation.

Essential Duties & Responsibilities:

• Processes site payments for clinical studies managed internally by the Clinical Operations Team.
• Serves as the primary contact for sites regarding payment inquiries.
• Facilitates requests for clinical documentation from Company functional departments and outside vendors.
• Supports data collection and data entry for Sunshine Act Reporting.
• Oversees the development, maintenance, and reconciliation of the eTMF ensuring each is Internal Conference on Harmonization (ICH), Good Clinical Practice (GCP), and 21 CFR 11 compliant.
• Monitors and performs quality checks of electronic Trial Master Files (eTMF) for accuracy and completeness; corresponds with internal staff, Clinical Research Officers, and eTMF vendors to ensure documents are uploaded in accordance with TMF plans in a timely and efficient manner.
• Supports ongoing revision of TMF Structure(s) to align with the Clinical Data Interchange Standards Consortium (CDISC) Reference Model.
• Performs audits of eTMF documents and creates status and activity reports for eTMF application platforms.
• Attends and participates in internal and external meetings and trainings.
• Other responsibilities and projects as assigned

Supervisory Responsibilities:

• N/A

Knowledge & Other Qualifications:

• High school Diploma and four years of relevant experience is required or a bachelor's degree with two years of relevant experience.
• Excellent organizational, multitasking, and problem-solving skills with exceptional attention to detail.
• Excellent interpersonal and communication skills in English language (writing, speaking, and comprehending).
• Proficient in Microsoft Office Suite including Word, Outlook, Excel, Acrobat, Access (strong focus), SharePoint, and some knowledge of Smartsheet.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability of having an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• The worker is not substantially exposed to adverse environmental conditions.

Compensation:

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $60,000 to $75,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.

Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs.

Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.