Viveve is a thriving medical device company focused on providing innovative high- quality products and treatment options to improve women’s health and wellness.
Our revolutionary technology is sold worldwide and is benefiting the lives of women around the globe. Viveve’s corporate headquarters is located in the thriving Denver Tech Center in Englewood, Colorado. We are consistently seeking talented individuals to join our dynamic team.
We offer a competitive compensation and benefits package including stock options. Our corporate values include collaboration, integrity, agility and customer focus. We are committed to hiring a diverse workforce.
Clinical Program Manager
Provide clinical study expertise and support, lead sponsored clinical research studies.
Major Duties and Responsibilities:
- Provide operational support across multiple therapeutic areas for clinical studies.
- Oversee and lead one or more sponsored clinical research studies.
- Assist in the conduct of preclinical studies as needed.
- Oversee CROs, clinical laboratories, and study monitors during clinical studies.
- Assist with regulatory submissions as needed.
- Work with Clinical Supply, Regulatory Affairs and Quality with regards to clinical studies.
- Identify skilled and appropriate study investigators.
- Perform study visits, as appropriate.
- Anticipate and solve issues that arise during the conduct of a clinical study.
- Designing study materials and coordinating TMFs.
- Providing clinicians with instructions on how to conduct the studies.
- Collecting and authenticating data collection forms.
- Monitoring progress throughout duration of study.
- Writing reports and review of CSR and study sub-reports.
- Assist Clinical Affairs team members in execution of data generating projects, including focused analysis of existing datasets and medical-team generated clinical research
- Collaborate with Program Managers and Clinical/Medical leadership to ensure Clinical Affairs objectives are met.
- Complete projects and tasks in a timely manner, with high quality and within budget.
- Keep management informed of changes in work schedule and/or workload.
- Support company goals and objectives, policies and procedures, Good Clinical Practices, and FDA/International regulations.
- Create work instructions/operating procedures, as appropriate.
- Ensure compliance with applicable requirements.
- Work effectively as a member of Clinical Affairs.
- Manage all projects while balancing company risks at each step
- Perform other duties as assigned
- Excellent verbal and written communication skills
- Must be willing to travel 50% of the time, both domestically and internationally
BS in science or healthcare field; Masters or PhD level preferred.
Minimum of two years of related experience in the pharmaceutical, biologics, and/or medical device industries.
Senior Project Manager
Responsible for the management and completion of multi-disciplinary corporate projects.
Basic Job Duties:
- Collaborate with the executive team and key business leaders on meeting business needs through project identification and execution.
- Apply project management skills and techniques to lead simultaneous cross-functional initiatives of varying complexities.
- Create and maintain detailed project management plans and other project documents.
- Manage projects in compliance with corporate SOPs and relevant regulations; liaise with other department managers as necessary.
- Provide solutions to project-related issues.
- Create budget estimates and track project spend.
- Work closely with cross-functional teams and third parties or vendors to ensure the effective completion of projects.
- Assign, prioritize, and supervise project tasks and task management.
- Participate in establishing practices, templates, policies, tools to expand and mature capabilities for the organization.
- Support company goals and objectives, policies and procedures, Quality Management System, and FDA/MDD regulations.
- Perform any other relevant, project-related duties when needed.
- Other duties as assigned.
SKills / Qualifications / Competencies:
- B.S. degree (Engineering or technical degree preferred)
- Prior experience in a PMO setting .
- Prior experience managing Contract Manufacturers and/or off-site teams
- 5+ years of project management with cross-functional teams
- 3+ years of medical device experience and/or manufacturing
- Able to excel in a fast paced, dynamic environment requiring flexibility in project management approach.
- Proficiency within and knowledge of Design Control, ISO 13485, and Good Manufacturing Practices.
- Experience with New Product Development and Manufacturing Transfer Projects.
- Able to work independently with little supervision.
- Proven success managing cross-functional projects successfully.
- Excellent written and verbal communication skills.
- Excellent analytical, organizational, and problem-solving skills.
- Thorough understanding of and ability to comply to applicable regulations and guidelines.
- PMP certification preferred
- Standard MS Office, MS Project and basic knowledge of ERP systems.
- 20% Travel
If you are interested in working with a committed group of individuals who are passionate about making a difference, we encourage you to send your resume to [email protected] and we will consider it in light of our staffing needs.
Viveve does not seek assistance or accept unsolicited resumes from search firms for listed employment opportunities. Viveve is an equal opportunity employer.