-
ID
#46351374 -
Job type
Permanent -
Salary
$140,000 - $175,000 per year -
Source
Jobot -
Date
2022-10-09 -
Deadline
2022-12-07
Associate Director, Clinical Research Project Management
Massachusetts, Waltham, 02451 Waltham USAPermanent
Vacancy expired!
- Competitive compensation
- M/D/V
- Bonus
- Responsible for all activities related to implementation of translational and/or clinical studies
- Responsible for on-budget and/or on-time study completion and compliance with all quality standards and applicable regulations from study start-up, enrollment, maintenance and close-out.
- Leads a Project Management team to ensure project quality, timelines, and targets/milestones are met or exceed expectations.
- Owner of the project plan and proposal and regularly liaises with finance to develop, revise, and review study budgets and client invoices. Act as the primary lead for the change order process with clients.
- Facilitates customer teleconferences and meetings and provides timely deliverables. Responsible for resolving any first level customer escalations.
- May independently prepare, coordinate, and present project material at internal and external meetings
- Provides oversight for the development and implementation of study documentation in accordance with the company QMS and study requirements.
- Directs the activities of assigned Project Support staff; provides line management and mentorship for project management team members as applicable and clinical staff; facilitates team building and communication
- Oversees interdisciplinary translational and clinical research programs ensuring compliance with ICH/Good Clinical Practices (Google Cloud Platform), relevant Standard Operating Procedures (SOPs) and all other applicable regulations
- Facilitates staff training and ensure that documentation is completed for internal project teams and provide support for the training for other relevant stakeholders that include the operations team and external vendors as applicable
- Identifies any potential risks to study timelines and conduct and proactively proposes mitigations and implements plans with cross-functional teams and the client
- Participates in the review and provides feedback on operational aspects of the study design and feasibility process
- Coordinates activities and deliverables of all project participants including the operations team and proactively identifies, communicates, and manages issues
- Prepares regular project management reports and dashboard updates for clients, internal teams, and management
- Responsible for the maintenance of project information on various databases and systems
- Works with the Quality team for project management components of audit inspection readiness including Trial Master File (TMF) and customer/CAPA form management. Provides the necessary sign-off for quality forms.
- Participates in special projects related to operational infrastructure as needed
- Proven experience managing projects involving multiple agile teams, including internal stakeholders outside your reporting chain and external partners
- Thorough knowledge and experience in clinical research from Phase I through regulatory submission
- Ability to manage multiple priorities within a variety of complex clinical trials and translational studies
- Excellent customer leadership skills; proactively anticipates, understands and responds to the needs of the clients to meet or exceed their expectations
- Ability to reason with data and logic independently for the purpose of assessing and recommending specific solutions in a clinical operations setting
- Ability to set baseline targets, track trends, and implement mitigation plans
- Demonstrated experience or ability to develop dashboards and metrics for Project management function
- Understanding of basic data processing functions, including electronic data capture
- Demonstrated problem-solving and financial negotiation skills
- Working knowledge of current ICH Google Cloud Platform guidelines
- Knowledge or experience in remote clinical research/trials that involves in-home visits is a plus
- Experience in a high growth, start-up environment is a plus
- Bachelor's degree
- 7+ total years experience in project management, program management, or clinical operations in clinical research
- Certified Clinical Research Professional (CCRP®) or active PMP certification or similar credential is preferred
- Demonstrated financial management skills required
- Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment
- Experience with clinical trial technologies including EDC, CTMS, ePROs and other data platforms commonly used in clinical trials
- Working knowledge of Word, Excel, and PowerPoint required
- Experience with Smartsheet & Salesforce preferred but not required
- G-Suite experience preferred
Vacancy expired!
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