Job Title: Associate Director, Clinical Operations
Salary: $165,000-$180,000
JOB SUMMARY:
Looking for an experienced Clinical Operations professional. The Associate Director, Clinical Operations will report to the Vice President, Clinical Operations. The role is primarily responsible for close interactive oversight to ensure exceptional execution of Oncology clinical studies. The Associate Director will also be accountable for leading departmental efficiency initiatives in support of department excellence.
The Associate Director will oversee all clinical studies across geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), regulatory authority guidance and directives such as Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) guidelines.
The Associate Director is accountable for operational planning at the study level with responsibility for clinical conduct (from planning start-up, conduct, reporting and close out) including timeline and quality. A key focus will be the interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines so that data is suitable for regulatory submissions and publications. The Associate Director will develop and maintain metrics-based tools to assess departmental and 3rd party performance on a quarterly basis to meet corporate goals.
The Associate Director will have routine interaction with key internal functional leads and external stakeholders communicating project status, escalating issues, troubleshooting routine inquiries. The Associate Director will participate in efficiency workstreams in support of cross functional collaboration.
Outside interfaces may include other Oncology business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations.
The Associate Director is a leader within Clinical Operations and will have no less than 2 direct reports. The Associate Director is accountable for employee trainings (related to therapeutic areas, protocols, and applicable operational processes). The Associate Director will mentor her/his direct reports in support of career development.
Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important. The ideal candidate for this role is an individual who is excited to take on new challenges in a dynamic environment. To be successful, the candidate is committed to collaboration and a data driven approach to align with the team's brand and culture.
PRINCIPAL DUTIES:
Study Management and Leadership
- Maintains oversight of operational study-level timeline and quality of deliverables
- Maintains oversight of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent and providing this data to Program Management as per agreed frequency
- Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management for assigned studies
- Lead the creation of the CRO scope of work in collaboration with key stakeholders for assigned studies
- Lead study feasibility and site identification activities in collaboration with the CRO and the study team for assigned studies
- Leads document review and coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND for assigned studies
- Monitor clinical study performance and quality metrics. Triage, resolve or escalate study issues /risk mitigations to the Vice President, Clinical Operations
- Develop and maintain metrics-based tools to assess departmental and 3rd party performance on a quarterly basis to meet corporate goals
- Ensure adherence to internal procedures for study planning, study conduct, close out and reporting
- Proactively assess potential risks to the study and propose mitigation plans
- Support all inspection readiness and quality initiatives for assigned studies
CRO, 3rd Party Vendor Management and Oversight for assigned studies
- Responsible for the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with quality measures and adherence to scope of work within timelines and budget at a task level. Specifically track operational study timelines and monitor operational performance metrics through the life of the study; Identify issues and propose solutions.
- Responsible for ensuring that the Clinical CRO(s) provide timely input and generate documents in a timely manner and with quality (e.g., communication plan, site monitoring plan, etc.) as per study plan
- Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan. Oversee and track site initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO.
- Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings, study team meetings, regional team meetings, safety committee meetings, advisory board meetings investigator meetings and training. Note that vendor management is not limited to the CRO, but includes 3rd party vendors (e.g., translations, study insurance, and central laboratory, etc.).
- Review CRO-generated reports such as monitoring visit reports, protocol deviation reports, and analysis of site metric reports. Identify areas of concern and either resolve, propose solutions, or bring to the attention of the operations lead of study team lead. Coordinate and liaise with QA on site audit and inspection activities.
- Conduct and/or oversee the CRO oversight monitoring visits as outlined in applicable plans
- Coordinate all operational activities under the guidance of the Vice President, Clinical Operations and Associate Director, Clinical Operations and liaise with CRO to support interim analysis, database lock and review of TLFs before and after database cuts and/or database lock Oversee CRO study close-out activities (including but not limited to TMF reconciliation) and liaise with internal Functions within the study team to ensure drug destruction process and other study close out activities are completed
Knowledge Management/People Management
In addition to providing instruction, direction of daily activities in support of goals, the Associate Director, Clinical Operations will:
- Support goal setting, provide input for performance review and provides feedback on a regular basis
- Assist or Lead training SOPs, GCPs, operational systems, etc
- The Associate Director will coach and guide their direct reports in support of their development needs, ensure individual development plans are in place; and will defer to the Vice President, Clinical Operations to facilitate conflict resolution on their behalf.
- Support Department in codifying existing knowledge and best practices; prepare training in area of expertise. Make recommendations for areas of improvement and innovation (study, or departmental level). Educate the team on adherence to SOPs, GCPs and on best application of operational tools and processes. May represent the organization as a prime contact for technical matters of significant complexity with the possibility of leading a cross-functional initiative or workstream.
REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):
- Bachelor's Degree in a Life Sciences
PREFERED QUALIFICATIONS:
- Minimum of 8 years' experience in clinical operations methods and processes in industry setting required
- Strong understanding of ICH, GCP, and relevant regulatory requirements
- Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word and PowerPoint
- Proactive and able to work independently
- Ability to prioritize and multi-task with attention to detail
- Strong organizational skills
Travel
- Ability to travel up to 30% In-house office position that may require travel (global)