Senior Project Manager

MDC Associates (MDC) is a full-service CRO dedicated to supporting innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world. Initially founded to provide Regulatory and Quality guidance, we identified a need for highly skilled Clinical Affairs, Clinical Operations, and Data Management services and built our CRO to best ensure our client's success. We're proud of our 35+ year track record providing guidance and resources that have helped to deliver next-generation advances in microbiology, clinical chemistry, infectious disease and companion diagnostics (CDx) that contribute to a healthier world.
The Senior Project Manager is responsible for achieving successful delivery and reporting of clinical activities for assigned projects to Clients/Sponsors and MDC management. This includes developing and maintaining project plans, timelines, and budgets, and ensuring that all activities comply with company policies.
Primary Responsibilities

• Ensure effective project plans are in place and operational for each project and work proactively with the Clinical Team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
• Ensure potential study risks are escalated to upper management when appropriate.
• Monitor project progress on an ongoing basis and provide summaries and feedback to the Study Lead, Management and Client. 
• Attend and take minutes for regularly scheduled teleconference meetings with clients and track progress and deliverables both internally and externally. 
• Review and approve vendor invoices in collaboration with the Accounting team to ensure payments occur in a timely manner.
•  Provide project-related support, including organization of documents, communications, and schedules, throughout the project lifecycle. Prepare and utilize project tracking tools to maintain timelines.
• Support in the development of new tools and processes to improve Project Management at MDC.
• Provide mentorship to other Project Managers.
• Train new Project Managers.
• Coordinate with Clinical staff to ensure studies are properly planned and executed, including selection of study sites, development of protocols and forms, and development of databases.
• Lead and assist with internal projects as assigned.

• Bachelor's degree or educational equivalent.
• Certified Associate Project Manager (CAPM), PMP Certificate, Certified Clinical Project Manager (CCPM) or similar certification or ability to obtain within first six months of employment. 
• Five or more years of clinical operations experience; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.

• Proven ability to communicate clearly with team members to offer mentorship, feedback, and training opportunities.
• Quick takeover of the management of ongoing complex trial(s), flexibility, and team working.
• Read, write and speak fluent English; internationally minded, with excellent verbal and written
  communication skills.
• Hands-on with an eye for the details, while able to oversee and manage vendors appropriately.
• Computer skills including proficiency in use of Office 365, Microsoft Word, Excel, Access, Outlook and PowerPoint.
• Ability to manage competing priorities without compromising quality.
• Up to 25% Travel including local, within U.S and outside of the US. Travel may include:
  • Attending off-site client meeting
  • Attending Clinical Site Initiation/Monitoring Visits
  • Attending conferences relevant to clients and industry

Pay 

• Salary Range $120k - $130k  
• Employee Stock Options.

Benefits

• Medical, Dental, and Vision Insurance.
• Health Reimbursement Account (HRA)
• Flexible Spending (FSA) / Dependent Care Accounts (DCA)
• Short and Long-Term Disability
• Group Term Life Insurance
• 401(k) with Safe Harbor Match
• Unlimited PTO
• 13 Paid Holidays

Equal Opportunity Employer

MDC is an Equal Opportunity Employer committed to a diverse workforce. MDC will not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, or membership in any other category protected under law.

We invite you to apply if you have an interest in learning more about MDC and joining our mission to provide diagnostic innovators with the exceptional support and personalized solutions they need to make our world a healthier place.