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- Responsible/Accountable for project related efforts for the delivery of studies or programs that are critical to a products clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
- Accountable for external vendor selection and management, and assists in the development of RFPs and vendor oversight plans
- leadership of the cross-functional study team, including external team members, CROs and vendors.
- Advises on strategic input on clinical operations pipeline and goals, including input in the overall clinical development plan on a global scale.
- Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA)
- Effectively lead, manage, and develop a team of direct reports who will manage multiple trials and multiple arms.
- Develops strong, collaborative working relationships with CROs/vendors, key investigators, and other key staff/vendors and cross functional study teams.
- Serves as a leader to proactively audit and inspect clinical operations activities for efficiency, quality, and progress.
- Partners with team, CRO and cross-function teams to facilitate site engagement and recruitment activities. Ensure site training/communications are occurring as needed.
- Oversees overall study progress, data collection and cleaning activities for all trials.
- Prepares study reports and provides ongoing updates for leadership team/meetings.
- Develops best practices and SOPs, as needed.
- Facilitate site contracting process, including helping with negotiations and managing site budgets
- Develop and implement robust risk identification and mitigation plans to solve complex issues that impact study or program milestones
- Disseminate clinical program communications to all functional groups and leads program, study and team meetings
- Support of Clinical Operations projects, infrastructure, and processes (e.g. SOP development and review, financial tracking for assigned project(s), management of clinical systems, oversight of clinical metrics tracking and reporting)
- BA/BS degree in Health or Life Sciences required, advanced degree preferred
- A minimum 10+ years of experience in Clinical Operations roles within the Pharmaceutical and/or Medical Device Industry, with heavy concentration within clinical trial management and monitoring and line management.
- A minimum of 5+ years of experience as a manager/leader
- Exceptional collaboration, communication, and interpersonal skills
- Advanced proficiency in Microsoft Office and Microsoft Project or Smartsheets
- Reliable, self-motivated, team player
- Detail oriented with excellent organizational skills
- Ability to effectively manage multiple tasks and competing priorities
Associate Director Clinical Operations - Boston, United States - Clinical Dynamix
Description
Associate Director, Early Development (Clinical Operations)
The Associate Director, Early Development Clinical Operations is responsible for leading projects to support the execution of clinical studies aligned with the clinical development plan according to the agreed upon timelines and budgets. This role reflects the knowledge, experience, skill levels and capacity to manage complex studies or programs.
Responsibilities:
Establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelines/budget established for the study/studies.
Requirements