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.

Requirements

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.

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

project managementclinical operationsrisk managementprotocol developmentdatabase developmentvendor managementproject trackingdocument organizationschedulingmentorship

Soft Skills

communicationteamworkflexibilityattention to detailleadershiptrainingfeedbackproblem-solvingtime managementorganizational skills

Certifications

Bachelor's degreeCertified Associate Project Manager (CAPM)Project Management Professional (PMP)Certified Clinical Project Manager (CCPM)