Senior Manager, Clinical Research

Reports to: Associate Director, Clinical Research
Position Status: Full Time
Location: Miami or New York or Telecommute

Description:

The Parkinson's Foundation (PF) makes life better for people with Parkinson’s disease (PD) by improving care and advancing research toward a cure. In everything we do, we build on the energy, experience and passion of our global Parkinson's community.

A prime focus of the Foundation is PD GENEration, a global, multi-center, genetic research study for people with PD.

The Senior Manager of Clinical Research will be a key member on the Clinical Research team, focusing on study operations for PD GENEration globally.  The role encompasses all aspects of clinical research including development of study project plans, Investigational Review Board (IRB) submissions, study start-up and maintenance, vendor management, reporting and publication of study results. The holder of this position ensures PD GENEration is executed within predefined timelines and budgets and are conducted in compliance with GCP and all applicable standards and regulations. These responsibilities require the Senior Manager of Clinical Research to possess exceptional judgment and a high level of knowledge of regulatory affairs in both US and ex-US markets.

Responsibilities:

Responsibilities include but are not limited to the following:

• Serve as PF liaison for trial vendors including CRO, Data Management, Genetic Testing Laboratory and external collaborators.

• Manage PD GENEration research coordinators (at least 1) and help them with strategy, planning, and execution of site management tasks.  

• Assist in site selection, enrollment and recruitment processes.

• Manage investigator budget and contract execution in collaboration with internal teams (Grantmaking Operations team) and at investigational sites.

• Prepare all documentation for the Trial Master File, including case report forms, informed consent documents, investigator agreements, case report form completion guidelines, logic checks and data handling guidelines and other required documents.

• Plan, monitor and report participant accrual and implement corrective actions as necessary to meet accrual targets.

• Assist with operational oversight of trials including report review, report preparation, review of monitoring plans, manual of procedures, data management plan, and other SOPs.

• Primary contact for cross-functional study team including Clinical Affairs, Community Engagement, Community Education, Development, Corporate Partnerships, Communications, Accounting and Finance.

• Provide accurate and timely study updates for internal and external stakeholders.

• Manage all vendor resources and activities to ensure study is being conducted according to protocol, timelines and budget.

• Prepare internal files and investigative sites for regulatory inspections.

• Complete closeout activities, including final reports.

• Maintain internal Quality System documents (SOP, etc.) in compliance with appropriate regulations.

• Travel to Foundation events with or on behalf of the Clinical Research team (10%).

• Participate in other projects and project teams as assigned.

Job Complexity

Job requires maintenance of up-to-date knowledge of all applicable clinical guidelines and international clinical regulation and regulatory guidance. 

Supervisory Responsibilities:

Supervises activities of external vendors and investigational sites.

Experience, Skills & Qualifications Required:

• Bachelor’s degree in the life sciences or health care field.

• CCRC or SoCRA certification preferred but not required.

• Minimum 5 years in clinical research within biopharmaceutical or medical device industry or site-based experience as a study coordinator.

• Direct clinical research experience and supervision of clinical studies as project leader or clinical associate is required; demonstrated knowledge of GCP.

• In depth knowledge of medical terminology and an understanding of the physiology and pathophysiology related to the relevant clinical trial.

• Excellent problem-solving skills with ability to resolve trial issues.

• Self-starter and excellent multi-tasking skills.

• Excellent project management skills and planning competencies to set plans and execute on time and within budget.

• Experience managing CROs and outside vendors to plan and execute Phase I- IV and/or observational clinical trials.

• Prior experience with EDC systems is required, ideally RedCap.

• Excellent computer skills, specifically with Microsoft Office Suite, is required.

• Professional presentation, verbal and written communication skills are required.

• Experience working with non-profit organizations on observational registry studies desired.

• Demonstrated ability to collaborate, multi-task and work effectively in a fast-paced environment.

• Demonstrates the organizational values of excellence, teamwork, collaboration, integrity, positivity, dedication and responsiveness.

Compensation:

Salary for this position is competitive and depends on prior experience. In addition, a comprehensive benefits package is included. The salary range for this position is $55,000 to $75,000.