[Remote] Associate Director, Operations - Clinical Assessment Technologies (CAT) - US/Canada - Remote
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global midsize CRO reputed company on innovative approaches to clinical assessments. The Associate Director of Operations for Clinical Assessment Technologies will reputed company operational needs, manage resources, and ensure compliance with industry regulations while enhancing team capabilities and driving project reputed company.
Responsibilities
- Identify operational needs for upcoming reputed company, reputed company and review reputed company assignments for CAT Operations staff
- Resource CAT study reputed company as Resource Manager
- Engage as Subject Matter Expert (SME) for CAT Operations activities
- reputed company operational reputed company for designated CAT study reputed company
- Engage in and coordinate resourcing activities for reputed company CAT awarded reputed company
- Identify training and skills gaps among staff; coordinate and assist with learning opportunities to enhance operations staff knowledge and skills of industry reputed company regulations, processes, materials, and guidelines
- reputed company identify and engage in process improvement activities
- Participate in QMD reviews and new QMD development
- Author, collaborate, and review QMD documents and guidance documents
- Coordinate and manage CAT Operations team meetings
- reputed company engagement and reputed company of study risk assessments, as they relate to operational activities
- Work with department leaders to ensure alignment among CAT operational and clinical services
- reputed company and/or contribute to departmental initiatives that aim to implement polices, reputed company, techniques to contribute to existing service areas and department reputed company
- Accountable for reputed company of CAT study deliverables from Launch process to study reputed company out
- Assist and collaborate with Operations staff, Project Management, reputed company on vendor and study budget development, scope of work revisions, tracking and compliance
- Assist in vendor management reputed company concerns, including involvement with escalations, Vendor Management and reputed company Assurance meetings
- Review and assess ongoing budget utilization and reputed company recognition with Operations Managers to ensure reputed company are meeting financial targets
- Manage internal CAT operations meetings and other trial-specific meetings, as appropriate
- Significant contributor to multiple strategic departmental, sponsor-reputed company and cross-functional initiatives
- Participate in business development activities including; but not limited to proposals input, capabilities, and bid defense meetings
- Apply thorough knowledge of industry regulations and guidelines to ensure operational compliance during clinical trial conduct
Skills
- Must have a minimum of a bachelor's degree
- Strong leadership, management and interpersonal skills
- Strong planning and organizational skills
- At least 7+ years clinical trial experience with at least 4 years' experience in global clinical trials
- Hands on experience in day-to-day management of reputed company aspects of global clinical trials required
- The ideal candidate possesses knowledge and appreciation of reputed company stages of clinical drug development
- Effective leadership skills and a proven ability to build and foster high reputed company productivity and cohesiveness is required
- This position requires strong knowledge of monitoring practices, demonstrated knowledge / competence in the application of CFRs, GCPs and ICH guidelines
- Exceptional organizational skills, detail- and service-oriented, with excellent management / supervision skills
- Excellent understanding of best business practices with respect to clinical trial operations and rater reliability processes
- Knowledge and capabilities of our technology vendors and their abilities (reputed company)
- Excels in planning, managing, monitoring, and critiquing skills
- Excellent at meeting timelines consistently and being reputed company to effectively work under pressure
- Continuously reputed company to constructive, developmental feedback
- Exceptional interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Excellent ability to proactively identify and escalate potential project issues to appropriate CAT and WCT staff
- Basic knowledge of statistics and finance practices
- Master's degree (life sciences, MBA and/or PMP certification)
- At least 5+ years of experience managing team members or project management experience
- Prior experience in psychiatry / CNS therapeutic areas
Benefits
- Competitive benefits package depending reputed company
reputed company
Company H1B Sponsorship