Manager, Clinical Jobs Near Sunnyvale, CA

The Clinical Manager collaborates with multiple professionals to support and coordinate the provision / management of patient care; he or she works closely with clinical Directors, physicians and staf...

Continuously monitor client progress and adjust treatment plans accordingly. Write progress reports detailing client achievement, Meet directly with the therapy team in the field...

Proactively identifies potential study issues/risks and recommends/implements solutions; participates in and facilitates CRO/vendor selection process for outsourced activities...

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Prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions; participate in and manage project meetings and conference calls with CROs, vendors, and multi-functio...

Responsible for training, and developing members of the clinical operations team as well as outside vendors such as Clinical Research Associates on electronic clinical trial management systems...

Responsible for building an effective team, including identifying, recruiting and vetting Clinical Data Manager candidates, and for their professional development...

Develops timelines for data management activities, enrollment projections, and creates/modifies/reviews instructional materials in support of trial execution, including project and data management pla...

Work with Data Management to develop and maintain dashboards and KPIs representing metrics and trends related clinical trial sample testing and the status of clinical studies and present to study team...

Working knowledge of GCP and regulatory compliance guidelines for clinical trials and quality assurance procedures Experience in finance management (budget forecasting, change order management, etc....

Reviews site study documents for accuracy and completeness (e.g., informed consent template, study tools/worksheets, monitoring visit reports and letters, data listings, etc.) ...

Work with Data Management to develop and maintain dashboards and KPIs representing metrics and trends related clinical trial sample testing and the status of clinical studies and present to study team...

Meets regularly with Supervisors to discuss goals and progress and holds skip-levels with individual team members. Responsible for performance review of direct reports and overseeing performance revie...

Facilitate meetings, such as the cross-functional Study Management Team meetings or internal Clinical Operations team meetings

Participate in the introduction of assay improvements, new assay configurations and validation. Participate and comply with Quality and applicable regulatory requirements...

Lead the design and development of database and CRFs by collaborating with other functional area representatives in managing the development of database and CRFs, testing the functionality of the CRFs...

In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines...

Recruit, hire and maintain a high performing Clinical team to drive and achieve Company goals. Lead cross-functional project teams. Manage the planning, implementation, conduct and reporting of assign...

-Partners with cross functional teams to manage, adjust, and revise project timelines/budgets as necessary

Ability to write study protocols, study reports, and regulatory documents (e.g. IND, NDA, PRAC etc.) with little supervision

Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports...

Able to examine functional issues from an organizational perspective and work collaboratively with cross-functional team members

Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Referenc...

Oversee (and sometimes lead) the data management of Phase 1 through Phase 4 clinical trials in a large or complex development program.

Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols...

The Principal Clinical Data Manager acts as Lead Data Manager on complex to highly complex clinical studies and projects; either independently or by directing others, provides expert Clinical Data Man...