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Clinical Project Manager

1 month ago

San Diego, United States M&B Sciences Inc Full time
Job DescriptionJob DescriptionSalary:

Description:

As a Clinical Project Manager, you work together with our clients, internal team members, and vendors to directly improve and accelerate clinical research by keeping our projects running at optimal quality while staying on time and on budget. This will involve managing all project deliverables, and continuously providing feedback to your team to help improve overall performance and mitigate risks.

 

To fulfill our mission, we partner with patient advocacy groups, innovative digital health companies, data companies, clinical trial sites, and pharma/biotech to create an innovative model that empowers patients to connect with clinical trials. You will also be responsible for managing the relationships with advocacy groups and vendors on an as needed basis for the studies you manage.

 

Responsibilities Include:

  • Acting as primary liaison with clients, owning and growing client relationships to become a trusted point of contact to clients

  • Acting as primary liaison with clinical trial sites, working to onboard them to the M&B Sciences platform and be their primary point of contact with M&B Sciences to ensure that they are supported in their daily operations

  • Constantly analyzing project requirements, implementing prompt resolution of issues, and ensuring that M&B Sciences’ obligations to the client are delivered on time, follow high quality standards, and meet client expectations

  • Monitoring and reporting daily performance against existing service agreements, providing insight into potential risks, and identifying causes for all aspects of client delivery performance failures

  • Manages the operational aspects of weekly client meetings and ad-hoc client meeting requests including everything from agenda development, content to present through to action item review and closure

  • Ability to successfully manage client expectations when project priorities and demands shift quickly

  • Providing internal stakeholders with key program updates and development timelines

  • Able to manage multiple competing priorities and operate with clear understanding of program goals and objectives

  • Ability to identify project risks and communicate plan for resolution both internally and externally

  • Wearing multiple hats as a lead, and individual contributor throughout the project

  • Distributing prioritization lists to project team members, adjusting task durations, proactively following-up to ensure task completion, updating project task delegations and workflow modifications as necessary

  • Managing vendor relationships as needed, ensuring our vendor partners deliver against time, quality, and budget targets for each project

  • Assist with researching trial protocols, competitive landscapes, and patient communities to determine appropriate scope of work and quote generation in contracts.

  • Overseeing client payment issues as needed, and communicating with the billing department regarding customer invoicing needs

  • Ensuring managed studies are progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.

  • Identifying sales opportunities and working alongside the sales team to contract new implementations, services, or platform access for clients

 

  • Performs other duties as assigned

 

Skills and Qualifications:

Clinical Research Competencies:

  • 5+ years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience
  • Education Minimum: College nursing diploma or Bachelor of health sciences, nursing, biomedical sciences, pharmacy, pharmacology, or a related discipline. 
  • Demonstrated understanding of the concepts, practices and procedures of clinical trial management and operations, patient recruitment and participant retention for clinical trials
  • Advanced knowledge and experience with GCP/ICH and local regulations
  • Current GCP training (updated every 2 years)
  • Technical aptitude and ability to learn new software programs and applications
  • Experience working with decentralized teams to drive a project forward is a plus
  • Experience working on global projects is a plus

Non-Clinical Experience:

  • Excellent organizational skills with high attention to detail is required
  • Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
  • Ability to manage, prioritize, and routinely report progress on multiple projects and tasks
  • Strong presentation skills to internal professionals and external collaborators
  • Excellent leadership and problem-solving skills
  • Excellent written and verbal communication skills
  • Experience in leading cross-functional teams to meet goals and metrics