We have an exciting Clinical Trial Manager opportunity and we are looking for a dymanic and passionate individual to join our team. Pediatrix Medical Group is one of the nation’s largest providers of prenatal, neonatal and pediatric services. Talented business professionals from diverse backgrounds choose Pediatrix because we are an exciting and innovative company that focuses on a team approach to improve the lives of patients everywhere.  We offer a diverse range of opportunities, competitive salaries and benefits, and a commitment to clinical excellence, we are confident that you'll love being a part of the Pediatrix team. 

The Clinical Trial Manager is responsible for ensuring studies adhere to the protocol, International Conference on Harmonization, Good Clinical Practice, Food and Drug Administration regulations, applicable Standard Operating Procedures, and relevant policies and regulations.  Effectively manage aspects of assigned Research Applications through the Pediatrix Research Application submission and approval/closure processes through the Research Advisory Committee and Pediatrix Clinical Research Policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Study Management:

1. Manage the operational aspects of assigned Research Applications through the Pediatrix Research Application submission and approval/closure processes through the Research Advisory Committee and Pediatrix Clinical Research Policies.
2. Manage aspects of the 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.
3. 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 Senior Clinical Trial Manager, Legal, Finance, Coding, Compliance Departments and Site/Sponsor representatives as applicable.
4. 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.
5. 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.
6. Utilize Salesforce contracting automated support system for all legal contracts to support assigned clinical trials.
7. Ensure timely, accurate invoicing and site payments in collaboration with the Pediatrix Hospital Contract Revenue and Accounts Payable Departments and collaborate with a new Salesforce project for automated site payments.
8. Provide project status reports to the leadership team as requested, present project information in multiple forums, and effectively communicate key project issues.
9. Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
10. Audit Research Application files as assigned.
11.  Promote strong relationships with sponsors, hospital partners, and external business partners.
12. 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:

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

Experience/Education:

• Bachelor’s Degree required. (Degree in health related field preferred). 

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

• Society of Clinical Research Associates Certification (SoCRA) or Association of Clinical Research Professionals Certification (ACRPCP Certification), Certified in Healthcare Research Compliance (CHRC) prferred. 
• Expertise in drafting and reviewing technical documents, including protocols, contracts, budgets, informed consent forms, clinical study reports, and safety reports

Knowledge/Skills:

• Excellent interpersonal and communication skills.
• Strong organizational and management skills.
• Strong skills in resource planning, and the ability to work both autonomously and in teams.

Software:

• Clinical trial management systems.
• Proficiency in Microsoft Office (including strong Excel skills) and preferred skills in SharePoint and Salesforce.

Travel up to 20% may be required.

Benefits for Full Time employees and qualified dependents: 

• Medical, Prescription, Dental, Vision Insurance
• Progyny Fertility Benefits
• Livongo Diabetes Management
• Teladoc Health and Second Opinion Services
• Smart Shopper
• 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
• Various Discount Programs

*Part Time Regular employee classifications also receive this benefit

**Available to part-time regular and part-time casual employees aged 21 and over

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.

#LI-Remote

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.