Associate Director, Clinical Operations
4 weeks ago
**Role: Associate Director, Clinical Operations
**Who are we looking for?
- You have been working effectively in an independent trial management role for at least 3 years and are looking for an invigorating role where you can work autonomously on a high profile company program to execute study deliverables with quality.
- You are an energetic and passionate Clinical Operations professional who likes to think outside of the box, proactively seeks out and recommends process improvements and is passionate about the company’s mission of discovering and developing new medications
- You are a resourceful self-starter and team player with a strong results orientation
- You are open and authentic and can develop trusting relationships to move projects forward despite challenges.
- You act like an owner and take accountability; you are reliable
- You have strong written and verbal communication and know how to seek clarity in ambiguous situations
**What are we looking for?**
- A driven professional who is comfortable supporting the development of procedures in parallel with doing the work
- A collegial team player who enjoys working in close collaboration with external vendors and teams; someone who understands the criticality of vendor partnerships for the execution of clinical trial conduct
- A person who thrives in a small company atmosphere and is willing to “roll up their sleeves” to support all aspects of clinical trial execution (some CTA tasks through program management)
- A person who acts with a sense of urgency and a quality-mindset
**What are we offering?**
- Membership within a growing, supportive, highly connected and collegial organization
- Being part of passionate, involved, fun and cutting-edge Clinical Development Team - the ability to wear multiple hats and gain exposure to many aspects of the business
- Ability to develop within Clinical Development Operations under strong mentorship; future potential opportunity to be a line manager and develop a team
- Exposure to pioneering science and the discovery of drugs to help treat patients with cancer
**What you will do**:
- Leads the activities of the protocol level team as it relates to study-level strategy, timelines, goals, and quality; Liaises with cross functional team members for coordination of clinical study support to include but not limited to drug supply management, quality management, regulatory management initiatives
- Participates on the molecule Program Team
- Evaluates, selects and ensures appropriate oversight of Contract Research Organizations (CROs) and other external vendors. Builds solid relationships with key counterparts at CRO(s) and other external vendors; participates in CRO Governance, where applicable
- Coordinates the development and distribution of critical study documents, including Informed Consent Forms, operational documents, study reference documents, site materials, trainings and other study related documents; supports the development of clinical study protocols, clinical study reports and other documents as needed
- Communicates with clinical trial sites as appropriate to ensure optimal Sponsor-Site relationships
- Communicates trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities, and deliverables
- Develops and manages the study-level budget(s) and demonstrates accountability for the management of the budget through facilitation of WOs, CNFs and change orders according to study needs and tracking vendor performance against scopes of work, contracts, and invoices; manages budget forecasting and accruals in collaboration with Company FP&A.
- Analyzes clinical study and investigative site risks and implements corrective actions, where required
- Provides oversight of the applicable study drug(s) including supply projections, and partners with the Clinical Supply Chain for study drug distribution, labeling and destruction
- Performs quality assurance checks (e.g. reviewing protocols for operational effectiveness, monitoring trip reports for potential gaps in site/CRA training, conducting co-monitoring visits at clinical sites, reviewing data listings at interim analysis milestones)
- Supports and collaborates with GCP QA during site/study audit and vendor selection/auditing activities
- Leads Clinical Operations preparation of inspection readiness activities for FDA and other applicable regulatory body audits and/or meetings
- Owns the Trial Master File for assigned trials; ensures appropriate quality oversight and QC of required elements of TMF
- Maintains internal document repositories (e.g. Sharepoint)
- Assists with identifying and implementing best practices and continuous improvement plans within the company
- Participation in SOP, work instruction, and/or template development and review, as required
- Performs administrative functions and additional duties as assigned and appropriate
**What you will bring:
- A deep understanding of Clinical
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