San Mateo Metro Area,
Job Number: JN -082020-4504
Our client, a global life sciences leader, has an immediate need for a Clinical Trials Manager, to provide guidance and daily oversight for the successful management of all aspects of international clinical trials.
- Coaches members of a work team and ensures adherence to established guidelines.
- Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials.
- Anticipates obstacles and client difficulties and implements solutions to achieve project goals.
- Assists CPM in revising project timelines/budgets as necessary.
- Works with management on departmental issues, providing input to clinical operations strategies and work plans.
- Communicates with functional peers regarding project status and issues and ensure project team goals are met. Contributes to development of abstracts, presentations and manuscripts.
- Participate in the recruiting and hiring process for CPA/CRAs and support their professional development.
- Participate in training of CPAs and CRAs.
- Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.
- Travel is required
- Excellent interpersonal skills and demonstrated ability to lead is required.
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Strong communication and influence skills and ability to create a clear sense of direction is necessary. Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
- Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
- Experience in developing RFPs and selection and management of CROs/vendors. Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
- Ability to examine functional issues from a broader organizational perspective.
- Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
Having been in business since 2006, Vivo is a full-service recruiting and consulting company, specializing on mid to senior level technology resources. Our brand promise is simple: we get people. We get that our clients don t want to waste time, and that our candidates and employees thrive when given honest feedback and an opportunity to grow.
Whether you re onsite at our Pleasanton headquarters or working for one of Vivo s clients the best brand names out there our promise to you is unwavering: we will treat you like you are our most important employee.
Do you think you get people get what they really need, and get how to deliver? We re not perfect but we re accountable. We re not in 32 countries, but we are in the heart of it all. So, if you are looking for a flexible, fun and high-energy work environment, along with the opportunity to work with some of the world s technology leaders, we can t wait to talk to you.
Vivo We Get People!