Sr. Clinical Research Project Manager
Ultimate Staffing Services Irvine, CA
- Expired: January 19, 2021. Applications are no longer accepted.
Job DescriptionA large, global medical device company in Irvine, CA is looking to identify a Clinical Project Management Manager.Job Duties: Manage clinical trials activities and ensure all applicable regulatory requirements are met. Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for high-profile, larger and more complex clinical trials in accordance to GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s) Provide direction, guidance, and oversight of clinical core teams to execute high-profile, larger and more complex projects for multiple clinical studies and initiatives.
Determine clinical trial resources and set priorities for projects Manage project status and appropriate communication both internally and externally including key opinion leaders. Present trial information at executive and/or industry... conferences Analyze trial performance to plan and develop corrective actions.
Anticipate and communicate study risks and lead in the implementation of mitigation strategies Build an effective and efficient clinical project team. Provide mentoring and coaching to other project team members. Oversee the selection of clinical vendors and study sites Manage and oversee the preparation of clinical portions of IDE and PMA submissions Other incidental duties.Skills: Proven successful project management skills Proven expertise in usage of MS Office Suite (advanced Excel) and MS Project Proven expertise Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives Ability to demonstrate how they would be a mentor Proven successful project management skills Recognized as an expert in one or more areas with broad-based advanced knowledge within the organization Expert knowledge and understanding of corporate policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols Expert understanding of regulatory submissions, reporting, and audits Ability to manage confidential information with discretion Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment Represents leadership on projects within multiple areas, interfacing with project managers, clinical team and middle management Consult in project setting within multiple areas, interfacing with low to middle management Provides leadership to outsourcing partners on a task level, participates on small scale RFP Adhere to all corporate rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlEducation and Experience: Bachelor's Degree in in related field, 7+ years of experience in Project Mgmt, 10 years of previous related experience in Clinical Research Required or Master's Degree or equivalent in in related field 7 years of experience in Project Mgmt, 8 years of previous related experience in Clinical Research Required Experience working in a large manufacturing company Preferred.Company DescriptionWe are an equal opportunity employer and make hiring decisions based on merit.
Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the