Senior Clinical Project Manager
About Baudax Bio
Baudax Bio, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative products for patients in acute care settings. Baudax Bio, formerly the Acute Care Division of Recro Pharma, Inc. (REPH), spun-out from Recro in 2019. We are committed to bringing clinically meaningful therapeutic options to patients, health care providers, and payers, such as our lead product candidate, injectable meloxicam. We believe we can create value for patients and shareholders through our robust pipeline of product candidates. In addition, we continue to evaluate acquisition and licensing opportunities which align with our core acute care focus.
The Senior Clinical Project Manager will use clinical and scientific knowledge as well as leadership and influencing skills to lead, plan, and manage clinical studies in support of the clinical development plan.
MAJOR DUTIES & RESPONSIBILITIES
A) Essential Duties for each project
- Communicate study timeline expectations to internal and external study team members.
- Develop creative solutions for study recruitment challenges and lead implementation with study sites.
- Lead creation of risk management plan for assigned studies and propose strategies to mitigate timeline and quality risks.
- Create and manage review of project documents, e.g., CRFs (or EDC equivalent), ICFs, recruitment materials, clinical monitoring plans, operation manuals, SOPs, etc.
- Participate in review of protocols, IBs, and clinical sections of NDAs, sNDAs and INDs (including annual reports).
- Negotiate site study budgets.
- Oversee monitoring of study sites by contract CRAs.
- Co-conduct site initiation visits and interim monitoring visits as necessary.
- Lead planning and implementation of investigator meetings.
- Track study progress with appropriate metrics for recruitment, payments, etc.
- Respond to study site questions and escalate internally as appropriate for resolution.
- Manage selection of investigational sites vendors.
- Travel of 15-20% depending upon phase of project.
B) Supervisory Responsibilities
- No direct reports. Will be expected to provide mentoring in areas of expertise to other team members.
- Requires a Bachelor’s Degree in a discipline relevant to medicine, human disease, or pharmaceutical development.
- Minimum 6 years of relevant experience in the pharmaceutical industry with at least 3 years’ experience in a clinical operations role. Small company experience preferred.
- Management of Contract Research Organizations (CROs) in the execution of multi-center clinical trials.
- Authorship of clinical documents (ICF templates, clinical monitoring plans, operational plans).
- Experience in leading Phase III and late phase studies, domestic and international.
C) Knowledge, Skills and Abilities
- Thorough understanding of clinical data management, clinical trial management (including site monitoring), and regulatory compliance.
- Knowledge and understanding of ICH GCP and FDA Code of Federal Regulations.
- Strong interpersonal skills. Ability to influence without authority.
- Good planning and organizational skills.
- Effective oral and written communication skills.
- Ability to effectively interact and communicate with internal stakeholders, external vendors, and clinical site staff at various management levels.
- Flexibility and willingness to adjust to changing priorities. Ability to work in a fast-paced environment.
- Proficient in computer applications such as Word, Excel, and PowerPoint.
- Willing and able to travel.
Please fill out the form below to submit your application.