Clinical Project Manager - New Jersey
TMC is looking for an enthusiastic self-motivated Clinical Project Manager who will manage multiple aspects of clinical operations towards clinical trials and product lines to assure the standards of clinical study execution.
We’d love to hear from you.Apply now
| Your challenges?
You will be responsible for managing all aspects of a clinical trial or multiple clinical trials including CRO & vendor selection and oversight to ensure patient safety, adherence to the contract, protocol and appropriate safety regulations and data integrity, provides oversight and mentorship to clinical project managers. You will ensure compliance to SOPs, organize and lead CRO/vendor meetings, maintain study timelines, and provide study updates to internal line functions and management team.
- Provides oversight and leadership to fellow project managers.
- Serves as primary contact and resource for Lead CRA, CRO and vendor personnel. Supports selection and provides oversight and management of consultants and vendors.
- Tracks and reports on the progress of assigned clinical trials including budget and timelines.
- Executes project plans including management of schedule, cost, resources and deliverables (e.g. protocol, database development, reporting).
- Leads various teams (including CRAs, CTCs, Data Management, Biostats) to create and manage study related documents.
- Oversees data clarification process as needed to insure database lock according to agreed timeline.
- Maintains up to date knowledge of published literature in relevant therapeutic areas including a broad awareness of neurovascular issues.
- Ensure quality of Monitoring Team. Ensures that studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations and departmental SOPs.
- Ensures appropriate oversight of CRO and vendors.
- Organizes and participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops, and Team Training.
- Leads the preparation of clinical documents in support of regulatory requirements including IDEs, IDE and IRB annual updates, briefing documents, CTAs, as requested.
- Develops and maintains positive relationships both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators).
- Manage the triage of clinical site questions to appropriate team members (Program Manager or Director as appropriate).
- Prepares and manages clinical trial site budgets.
- Fully supports the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).
| What do we expect from you?
- A minimum of a bachelor’s degree (B.S. or B.A.) or experience as a Medical Healthcare Professional required.
- Certified Clinical Research Associate (CCRA) preferred.
- Project Management Professional Certification preferred.
- A Master’s degree in business management preferred.
- A minimum of 8 years of experience in all operational aspects of managing clinical trials with studies conducted under US Regulations required.
- Proficiency in resource planning and clinical trial financial management required.
- Must have a demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations required.
- Experience monitoring medical device studies preferred.
- Previous experience within a Sponsor organization or a Clinical Research Organization required.
- Work from home: Remote
- Travel Percentage: 30%
| What can you expect from TMC?
TMC is an international high-tech consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster changing technological world.
At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.
As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.
| Why choose for Employeneurship?
We are truly unique thanks to our Employeneurship model which is a true innovation for the High Technology consulting business. It is the business relationship of the 21th century for high skilled technical professionals. It is built around 5 main pillars:
- You will have a permanent employment contract, offering you stability and security
- You will get to know your market value and have a share in the profit your work generates thanks to the individual profit sharing
- We will support you with a one-on-one coaching and trainings designed to help you develop your entrepreneurial skills
- The competence cells structure, provides you with a strong meaningful and relevant network
- The entrepreneurial lab: a playground for new ideas and a potential launching for start-ups
TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Is TMC a perfect fit for you? We’d love to hear from you.
Feel Free to Contact
Talent Acquisition Specialist, North America
Tel: +1 (438) 686 5994