Senior Clinical Development Process Manager

Nature and Scope

Responsible for the execution of Clinical Development activities within the assigned area. This includes managing CR&D internal databases regarding specific Clinical Development projects, monthly clinical development status reports, and overall activities including the Protocol Review Monitoring Committee.  In collaboration with the Clinical Operations Process Manager, provide Clinical Development insight in the authoring, revising and maintaining department SOP’s. Manage Clinical Development surveys and dashboards.  Manage the clinical development process regarding new pipeline projects, facilitation collaboration within the CR&D department, other departments, and consultants as necessary. In collaboration with the Medical Affairs Department is responsible for the review of educational programs and grant requests from health care providers for merit and support.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Clinical Development Process

• Manage and maintain the CR&D Projects dashboards.
• Manage the monthly clinical development status report in collaboration with each project team withing the CR&D department.
• Develop and manage CR&D internal surveys, ensuring the accuracy and reliability of data collection processes.
• Manage the activities of the Protocol Review Monitoring Committee, including meeting minutes, mailbox, and communications to the study or project teams.
• Partner with Clinical Operations Process Manager to provide clinical development insight in the SOPs projects.
• Collaborate with Compliance, IT, HR, Procurement, Finance, Legal and other departments.
• Participate in special projects as needed.

Compliance and Documentation

• Ensure adherence and comply with company policies and regulations by sharing procedure and policy documents to CR&D and requesting feedback to verify understanding.
• Responsible for review and submissions of all Programs and Grants Committee (PGC) requests and Fair Market Value (FMV) requests for CR&D.
• Partner with Clinical Trial Process Manager on annual compliance reports for CR&D.
• Responsible for complying and distribution with updating the Annual Engagement Plan (AEP) for CR&D.
• Partner with Clinical Trial Process Manager on record retention reporting and tracking for CR&D and QSci  
• Perform any other tasks/duties as assigned by management.

Management of Grants in collaboration with Medical Affairs (as needed):

Work with Senior Director/Director of Medical Affairs to coordinate continuing education

• Presentations and symposia.
• Lead the development and execution of the overall independent medical education grants strategy and operations.
• Responsible for all operations pertaining to Medical Education requests including system enhancement, vendor management, customer inquiry processes, contracting, financials/reconciliations and outcomes/program assessments and related reporting for all supported programs.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Medical degree (M.D., DO, PHARMD, PHD) required
• Minimum 5 years’ experience in pharmaceutical clinical development, academic research, or a clinical research organization (CRO), with evidence of successful ongoing career development.
• Excellent oral and written English communication skills. 
• Experience with the US Food and Drug Administration is desired but not required.
• Ability to make decisions independently and with appropriate input.
• Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, and Medical Affairs.
• Attention to detail, diligence and dedication.
• High level of interpersonal skills and ability to work effectively in a cooperative and collaborative manner with all levels across functional teams both internally and externally is required.
• Experience working on problems of moderate complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is required
• Experience with project planning and implementation skills in a cross-disciplinary and multi-cultural team are required
• Strong interpersonal, verbal and written communications and organizational skills

Expected Salary Range:

$138,800- $150,000

The salary range, displayed is the  minimum and maximum annual salary range of comp