Manager, Regional CRA Network
Posted on: August 2, 2022
Job Description 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: 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. Support and resolve escalation of issues from
regional CRAs. Provides training, support and mentoring to the team
to ensure continuous career development. 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
Keywords: Supernus, Rockville , Manager, Regional CRA Network, Executive , Rockville, Maryland
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