Clinical Program Manager
Irvine, California
Employer: System One Holdings, LLC
Industry:
Salary: $120 - $150000 per year
Job type: Full-Time
Title: Program Manager
Client: Client is a nonprofit global leader in research, patient care and innovation for improving & extending the lives of children with MS
Address: Irvine, CA
Salary Range: $120-$150,000
Top 3 Responsibilities of the job:
1. Patient Advocate Support and Help to the Patient Care Coordinators
2. Contracts & Budgets
3. Collaborate and Manage Vendors
Job Description and Responsibilities:
Qualifications:
Bachelor's degree with 3+ years of prior related professional experience in research operations at a medical center or CRO, with at least 1 year in a project lead role.
Client: Client is a nonprofit global leader in research, patient care and innovation for improving & extending the lives of children with MS
Address: Irvine, CA
Salary Range: $120-$150,000
Top 3 Responsibilities of the job:
1. Patient Advocate Support and Help to the Patient Care Coordinators
2. Contracts & Budgets
3. Collaborate and Manage Vendors
Job Description and Responsibilities:
- Data Management and Systems Management
- Responsible for database design and form creation/management.
- Responsible for overseeing data clean up/scrubbing
- Responsible for multiple technical platforms and cross-platform integration.
- Leads build-out of additional features and deployments.
- Responsible for overseeing CRC activities, and occasionally providing direct support with: medical record data abstraction into the EDC platform, resolving queries, monitoring for alerts and flags of potential data entry errors, evaluating and resolving as needed.
- Researcher Support
- Manages incoming research requests. Tracks DUAs, MTAs and CTAs, ensuring IRB approval is in place where appropriate. Point of contact for researchers after project approval; provides system access and training to researchers.
- Tracks research requests and confirms contractual obligations are met.
- Supports internal research requests and projects; prepares abstracts, posters and talks.
- Project Management
- Creates spreadsheets to monitor deliverables, milestones, and key performance indicators.
- May lead advisory board meetings, preparing agendas/invites and taking minutes.
- Monitors and meets deadlines for project updates/releases.
- Collaborates with CRO on regulatory submissions and updates.
- Prepare and track invoices (inbound and outbound)
- Vendor Management
- Attends weekly meetings with project vendors, preparing agendas and recording meeting minutes.
- Reviews contracts and budgets. Ensures vendor timelines are met. Monitors for operational/logistical issues and poses solutions.
Qualifications:
Bachelor's degree with 3+ years of prior related professional experience in research operations at a medical center or CRO, with at least 1 year in a project lead role.
- Experience with EDC and EMR/EHR platforms and entering (required) and analyzing (preferred) clinical data. Database design (e.g., Redcap or other) strongly preferred.
- Vendor management experience strongly preferred.
- Experience with start-up and close-out activities strongly preferred.
- Experience in at least one of the following research areas strongly preferred: longitudinal research, patient registries, biobank.
- GCP and HSP certified (preferred), or completion within first month upon hire.
- Fluency in English (required); bilingual (Spanish) preferred.
- Exceptional patient/customer service skills (required), with familiarity of de-escalation techniques (preferred).
- This position requires initiative and the ability to problem-solve complex issues and requires a highly motivated individual with excellent follow-through, record. keeping/organizational skills, attention to detail, and communication skills. Accountability and dependability are key.
- Ability to perform well under pressure and to work independently and as a member of a team.
- To perform this job successfully, an individual should be highly skilled in Microsoft Office platforms such as Excel, Word, Outlook, SharePoint (required) and have demonstrated the ability to quickly learn to use and navigate technical platforms/systems (required).
Created: 2024-06-22
Reference: 317262
Country: United States
State: California
City: Irvine
ZIP: 92617
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