Job Summary: To provide oversight and leadership to the Clinical Data Management team in support of Clinical Development activities.
Essential Duties & Responsibilities:- Develop and maintain processes and SOPs for clinical data management activities.
- Establish and manage data capture, management, and review standards to ensure the quality and integrity of clinical research data in compliance with global regulatory requirements.
- Provide consultation, leadership, and expertise to the Clinical Development teams in the area of data handling and data management processes.
- Maintain Data Management timelines and metrics.
- Select and manage Data Management vendor.
- Monitor trends in team performance via quality, time, and cost indicators, and make recommendations for improvements.
- Coordinate User Acceptance Testing (UAT) and approve EDC databases.
- Develop and oversee the Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
- Oversee the development of Case Report Forms (electronic or paper) in collaboration with Biostats and Clinical Research and approve final versions.
- Participate in the review of clinical documents (e.g., protocols, case report forms, SAP).
- Coordinate the archiving of study databases and related documents.
- Write SOPs and contributing to the improvement of Data Management processes.
- Resolve and/or escalate issues encountered at the team level.
- Other responsibilities and projects assigned.
Supervisory Responsibilities:- Manages assigned Clinical Data Management staff.
- Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives.
- Understands Company Policy and procedure to be able to guide direct reports appropriately.
Knowledge & Other Qualifications.- Master's degree with at least 9 years OR Bachelor's degree with at least 11 years of experience in clinical and/or operational data analytics.
- At least 5 years of personnel management and project team leadership experience.
- Working knowledge of database applications.
- Proficient with EDC technology.
- Working knowledge of industry standards such as CDISC, SDTM, CDASH.
- Experience in CNS is preferred.
- Data Management Certification a plus.
- Budget forecasting/management a plus.
- Understanding of regulations governing clinical research (i.e., FDA, Health Canada), and ICH GCP guidelines.
- Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel.
Other Characteristics:- Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
- Ability to have 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 $162,000 to $190,000. 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.
You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.
