Clinical Trial Manager - Pediatrix

Overview:

 

 

Clinical Trial Manager

Responsible for ensuring studies are being conducted in adherence with the protocol, ICH Good Clinical Practice Guidelines (GCP), FDA regulations, applicable Standard Operating Procedures (SOPs), policies and any other applicable regulations.  Effectively manage aspects of assigned Research Applications through the Pediatrix Research Application submission and approval/closures processes through the Research Advisory Committee and Pediatrix Clinical Research Policies.Candidate will be required to have experience writing and reviewing technical documents, such as protocols, contracts, budgets, informed consent forms, clinical study reports, and safety reports.  This individual must possess excellent interpersonal and communication skills, organizational and management skills, resource planning, and the ability to work autonomously and in teams.  Computer literacy requires proficiency in the following programs:  Microsoft Office Suite/365, SharePoint and Salesforce. Minimal travel may be required.

Responsibilities:

Study Management:

• Manage the operational aspects of assigned Research Applications through the Pediatrix Research Application submission and approval/closures processes through the Research Advisory Committee and Pediatrix Clinical Research Policies.
• Manage aspects of assigned study(s)/project(s) as outlined in the protocol or project plan to ensure compliance with all applicable regulations and guidelines including but not limited to company and project-specific SOPs, budgets, contracts, and timelines.
• Coordinate the completion of research contracts (i.e., Research Agreements, Amendments, Nondisclosure Agreements, Data Use Agreements, Investigator Agreements, and any other contract type as needed) in collaboration with the Director of Clinical Trial Operations, Legal, Finance, Coding, Compliance Departments and Site/Sponsor representatives as applicable.
• Create and review study budgets as applicable; ensure budget completeness and fair market value pricing. Assure financial integrity of assigned projects to realize project goals and profitability.
• Manage Study contracts/budgets as assigned. Monitor project progress compared to established plans.  Prepare, reconcile, and analyze financial reports for sponsored trials and ensure trial revenue and expenses adhere to the contract budget.
• Utilize Salesforce contracting automated support system for all legal contracts to support assigned clinical trials.
• Ensure timely, accurate invoicing and site payments in collaboration with the Pediatrix Hospital Contract Revenue and Accounts Payable Departments.
• Provide project status reports to the leadership team as requested, present project information in multiple forums, and effectively communicate key project issues.
• Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
• Audit Research Application files as assigned.
• Promote strong relationships with sponsors, hospital partners, and external business partners.
• Work collaboratively with other departments to facilitate project success (i.e. legal, compliance, user services, finance, hospital contract revenue, coding, accounts payable, travel, marketing, etc.)

Other Duties:

• Review, complete, and follow the Pediatrix Compliance Training, Clinical Research Policies and SOPs, and CITI Human Subjects Protection training as required.
• Demonstrate commitment to the department objectives through consistent work behavior patterns and positive representation.
• Respond to department needs by accepting additional assignments which may or may not be related to the job’s primary responsibilities to ensure the continuity of department services.
• Attend professional meetings, seminars, or conferences as required
• Maintain awareness of the overall development in the field of clinical research as well as assigned area's

Qualifications:

Education required: Bachelor’s Degree in a health-related field. 

Education preferred:Master’s degree or similar education in a clinical field, clinical research administration, or business administration.

 

Skills required: Excellent verbal and written communication skills, ability to work independently and within teams, experience in Microsoft Office Suite/365, SharePoint and Salesforce

Skills preferred:Previous experience with electronic data capture systems and clinical trial management systems

 

Certifications preferred:Society of Clinical Research Associates Certification (SoCRA) or Association of Clinical Research Professionals Certification (ACRP-CP Certification), Certified in Healthcare Research Compliance (CHRC)

Benefits and Compensation:

• Medical, Dental, Vision Insurance
• Progyny Fertility Benefits
• Teladoc Health and Second Opinion Services
• 401(K) Thrift Program & Sharing Plan**
• Employee Stock Purchase Plan (ESPP) – 15% discount*
• Basic Employee; Spouse; Child Life Insurance
• Accidental Death and Dismemberment (AD&D)
• Employee Optional Life and AD&D
• Short & Long Term Disability
• Pre-Tax Health Savings Accounts (HSA)
• Employee and Dependent Flexible Spending Account (FSA)
• Family Medical Leave Act (FMLA)
• Parental Leave Benefit
• Sick Pay Bank
• Employee Assistance Program (EAP)
• Group Aflac Policies
• Identity Theft Protection
• Employee Charitable Fund
• Care.com
• Continuing Education Assistance
• Various Discount Programs

About Us:

 

Pediatrix Medical Group is one of the nation’s leading providers of highly specialized health care for women, babies and children. Since 1979, Pediatrix has grown from a single neonatology practice to a national, multispecialty medical group. Pediatrix-affiliated clinicians are committed to providing coordinated, compassionate and clinically excellent services to women, babies and children across the continuum of care, both in hospital settings and office-based practices. The group’s high-quality, evidence-based care is bolstered by significant investments in research, education, quality-improvement and safety initiatives. 

 

Please Note: Fraudulent job postings/job scams are becoming increasingly common. All genuine Pediatrix job postings can be found through the Pediatrix Careers site: www.pediatrix.com/careers.

Pediatrix is an Equal Opportunity Employer:

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.