Associate Director, Clinical Operations will lead study level activities in the Oncology pipeline while having the ability to multi-task on other company wide initiatives and activities. The incumbent will ensure all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines.
- Responsible for the development and presentation of status reports for the Senior/Director of Clinical Operations. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
- Leads the assigned cross functional study team fostering a collaborative team culture while ensuring goals and timelines are met with quality, in compliance of SOPs and regulatory guidelines. Identifies and/or anticipates risks and plans accordingly for mitigation and escalates issues to management as necessary.
- Provide strategic input, management and oversight of enrollment (including forecasting and modeling), clinical supply and drug supply, Trial Master Files, data review, data cleaning and oversight of database lock plan, and assist with the writing of clinical study report.
- Contribute to the development, review and approval of study documents including but not limited to protocol, ICF, clinical monitoring plan, EDC/Case report Forms, pharmacy manual, oversight manual and statistical analysis plan.
- Management of the CRO/Vendors and risk mitigation strategic input to ensure goals and deliverables are met with quality in per contracted scope of work and in compliance with ICH/GCP and regulatory guidelines.
- Supports serious adverse event (SAE) narrative writing by tracking and filing of the narratives and filing council for international organizations of medical sciences (CIOMS) reports
- Management and meeting coordination of the members of our data safety monitoring boards (DSMB) and clinical event committees (CEC).
- Review of key data points to include key efficacy and drug safety data via an Electronic Data Capture system.
- Supports the development, management and tracking of trial budget(s) working closely with the appropriate partners. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems. Facilitation of Clinical Agreements through Clinical and Legal review.
- Provide monitoring oversight including authoring of oversight plan, reviewing monitoring visit reports and conducting sponsor oversight visits (as needed).
- Assists medical writer in overseeing the process and timelines of writing, and tracking protocols, consent forms, and amendments to ensure adherence to regulations, company SOPs and processes.
- Contributes to Global clinical / regulatory submissions (FDA, EMA, Canadian and other countries), IRB / EC submissions, review and approval of regulatory packages (as needed), assisting with in house and site inspection readiness planning and training.
- Provide mentorship to clinical operations team members including review of work, resource allocation/time management assessment, training, support and guidance.
- Some travel will be required (10-20% depending on project needs).
Experience and Qualifications:
- 3 -5 years of direct clinical study management experience working in a full service outsource model as Clinical Trial Manager or Clinical Project Manager is required.
- 7-10 years of clinical operations management experience in a pharmaceutical or clinical research organization (CRO) setting; including managing personnel and vendors.
- Experience managing an Oncology clinical trial is required. Phase III Oncology clinical trial management experience preferred.
- Global Clinical Trial Experience and the ability to support more than one clinical trial is required.
- Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required; basic statistical knowledge required.
- Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) required.
- As key leadership competencies, this position builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Excellent communication skills, experience mentoring clinical study staff and presenting to senior management is required.
- Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems).
- Requires a BS or equivalent in the health or life sciences is preferred.