Supernus Pharmaceuticals
Senior Trial Master File Operations Associate
Supernus Pharmaceuticals, Rockville, Maryland, us, 20849
Description
Job Summary:The Senior Trial Master File Operations Associate is responsible for providing oversight for the management and quality control of Trial Master Files (TMF) to ensure compliance with regulatory standards. Incumbents in this role will work with cross-functional teams to ensuring accurate documentation throughout clinical trials while providing support to junior level staff and driving process improvements in TMF operations.Essential Duties & Responsibilities:Creates and manages Quality Management System (QMS) procedures in Veeva quality.Supports the implementation of clinical systems which includes planning, building, UAT testing, import/export of clinical data during migrations, and data archiving activities.Assists with tracking issues and observations for future enhancements, bug fixes, and ongoing needs for training of Clinical systems.Perform audits of electronic Trial Master File (eTMF) documents and creates status and activity reports as required.Monitors and performs quality checks of eTMFs 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.Oversees the development, maintenance, and reconciliation of the eTMF ensuring each is Internal Conference on Harmonization (ICH), , Good Clinical Practice (GCP), P and 21 CFR 11 compliant.Processes site payments for clinical studies managed by the Clinical Operations Team.Facilitates requests for clinical documentation from Company functional departments and outside vendors.Performs clinical data entry and validation to ensure accuracy, completeness, and legibility of data.Supports the development and evaluation of Clinical Operations Standard Operating Procedures (SOPs).Assists with the creation of training documentation to support internal processes.Trains team members on updated or current practices within Veeva clinical and other clinical systems.Attends and participates in internal and external meetings and trainings.
Supervisory Responsibilities:N/A
Knowledge & Other Qualifications:High School Diploma required, a bachelor's degree is preferredHigh School Diploma and six years of relevant experience, Bachelor's degree and four years of experience, or a Masters Degree with two years of experienceExcellent organizational, multitasking, and problem-solving skills with exceptional attention to detail.Excellent interpersonal and communication skills in English language (writing, speaking, and comprehending).Proficiency using Microsoft Office Suite applications 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 readingThe 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 $70,000 to $90,000. 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.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Job Summary:The Senior Trial Master File Operations Associate is responsible for providing oversight for the management and quality control of Trial Master Files (TMF) to ensure compliance with regulatory standards. Incumbents in this role will work with cross-functional teams to ensuring accurate documentation throughout clinical trials while providing support to junior level staff and driving process improvements in TMF operations.Essential Duties & Responsibilities:Creates and manages Quality Management System (QMS) procedures in Veeva quality.Supports the implementation of clinical systems which includes planning, building, UAT testing, import/export of clinical data during migrations, and data archiving activities.Assists with tracking issues and observations for future enhancements, bug fixes, and ongoing needs for training of Clinical systems.Perform audits of electronic Trial Master File (eTMF) documents and creates status and activity reports as required.Monitors and performs quality checks of eTMFs 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.Oversees the development, maintenance, and reconciliation of the eTMF ensuring each is Internal Conference on Harmonization (ICH), , Good Clinical Practice (GCP), P and 21 CFR 11 compliant.Processes site payments for clinical studies managed by the Clinical Operations Team.Facilitates requests for clinical documentation from Company functional departments and outside vendors.Performs clinical data entry and validation to ensure accuracy, completeness, and legibility of data.Supports the development and evaluation of Clinical Operations Standard Operating Procedures (SOPs).Assists with the creation of training documentation to support internal processes.Trains team members on updated or current practices within Veeva clinical and other clinical systems.Attends and participates in internal and external meetings and trainings.
Supervisory Responsibilities:N/A
Knowledge & Other Qualifications:High School Diploma required, a bachelor's degree is preferredHigh School Diploma and six years of relevant experience, Bachelor's degree and four years of experience, or a Masters Degree with two years of experienceExcellent organizational, multitasking, and problem-solving skills with exceptional attention to detail.Excellent interpersonal and communication skills in English language (writing, speaking, and comprehending).Proficiency using Microsoft Office Suite applications 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 readingThe 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 $70,000 to $90,000. 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.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)