Associate Director, Clinical Operations (Oncology)
Proclinical is currently recruiting for an Associate Director of Clinical Operations for a global biotechnology company located in Massachusetts. As the Associate Director, you will develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan.
- Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
- Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholders
- Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and client's SOPs
- Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
- Support the selection, oversight, and management of CROs and other vendors
- Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
- Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
- Manage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
- Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
- Along with other Clinical Development personnel, represent client's externally to Investigators, site staff, and Key Opinion Leaders
- Perform and document study level Sponsor Oversight of outsourced clinical activities
- Communicate study-status, cost, and issues to ensure timely decision-making by senior management
- Manage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programs
- Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
- Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
- Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
- Develop and foster strong, collaborative relationships with key stakeholders both within and external to the client
- Support program level deliverables/activities at the discretion of the Senior Director, Clinical Operations
- Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise
- Strive for continuous improvement and more efficient ways of working in clinical development
- Act as a role model for client's values
If you are having difficulty in applying or if you have any questions, please contact Anabel Balsebre at (+1) 646-779-7965 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.