Job Summary

Essential Duties & Responsibilities:

• Provides support to Clinical Operations in resourcing regional CRAs for planned and ongoing clinical trials.
• Ensures that clinical monitoring activities of the assigned team are performed satisfactorily, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.
• Monitor and evaluate regional CRA workloads and liaise with, the relevant Clinical Operation Lead and Assistant Director of Regional Network (as needed) to ensure appropriate allocation of resources and optimal utilization and workload.
• Monitor's performance of regional CRAs on a continuous basis including review of monitoring visit reports and attachments, ensuring quality documentation as well as appropriate and timely investigator site visit schedules.
• Conducts continuous regional CRA monitoring performance assessments (feasibility, qualification, interim, close out visits, for cause and other visits) and/or other training as warranted.
• Tracks clinical monitoring metrics such number of site visits performed, SDV/SDR performance, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, expense reports and required trainings.
• Manages and reviews systems (e.g. CTMS, EDC, eSource) to evaluate CRA project metrics, KPIs and general project status.
• Conduct regular team meetings to ensure appropriate communicate with the regional CRA team on program changes, policy changes, and priority shifts.
• Regional CRA Management:
  1. Identifies quality issues related to clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, Accompanied Site Visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions.
  2. Support and resolve escalation of issues from regional CRAs.
  3. Provides training, support and mentoring to the team to ensure continuous career development.
  4. Ensures regional CRA compliance to corporate policies, procedures, and quality standard.
• Ensures timeliness and accuracy of timesheets and expense reports.
• Establishes, manages, and conducts on-boarding program for new regional CRAs, ensuring smooth assimilation into the company.
• Participates in resource planning, including identification of resource options across the assigned programs and resource analysis across the assigned programs.
• Participates in process improvement initiatives as well as development and presentation of annual training material to ensure regional CRA team is up to date on best industry standards and approaches.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• Participates in special initiatives, as assigned.

Supervisory Responsibilities:

• Manages Direct Reports

Knowledge and Other Qualifications:

• 5 years of CRA experience
• 1+ years of Clinical Operations Management experience
• BA/BS or equivalent. Advanced degree preferred.
• Leadership, clinical project management, administrative, and technical capabilities are required.
• Effective verbal and written communication skills.

Other Characteristics:

• Willing and able to travel up to 25%, or greater depending on project needs, but should not exceed 50%
• Ability to work independently and as part of a team.
• Ability to maintain high ethical standards of integrity and quality.
• Capable of performing other duties as assigned by management.
• Proven supervisory skills and excellent verbal and written communication skills.
• Authorized to legally work in the United States without visa sponsorship.

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