Assoc Dir, Clinical Trial Management
Company: Cameron Craig Group
Posted on: February 12, 2019
Assoc Dir, Clinical Trial Management
The Associate Director is responsible to lead and drive clinical operations for their assigned global clinical studies/programs and to ensure the global clinical studies/programs are executed to support the successful registration of new products/indications.
They will manage resources, training and budgets for their GCTM teams. They will provide input to the operational strategy and into key documents for example study protocols and designs to ensure studies are operationally executable. They will ensure clear communication to senior management on operational updates. They will contribute to the DDO operational development by providing input and leadership in processes and working practices so that a continuous clinical quality process improvement is ensured.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. Thus, the percentage of time spent across key duties listed below for which the employee is responsible for or assisting with will vary.
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all company policies and procedures.
Main Areas of Responsibilities
Operations Study Lead (OSL)
The incumbent will be responsible for all study management aspects of a global clinical study including but not limited to all the tasks specified below. For all the global study activities, the incumbent will work with the Regional CTM(s) to ensure correlation of global study activities. The incumbent may also be asked to participate as a Global Clinical Trial Representative in cross-functional teams such as Protocol Review Team, Clinical Trial Team, Case Report Form Review Team, Clinical Study Report Review Team, and the Medical Safety Monitoring Plan Review Team. If a Corrective and Preventive Action is put in place, the incumbent may be asked to serve as the CAPA Lead.
Study concept, planning and strategy phase
The incumbent is responsible for: ensuring global study feasibility in collaboration with the FACT team and Regional CTMs (if global study) and summarize regional allocation of patients and resource; initial assessment of vendors needed; and the development of study specific documents and timelines as required.
Study Initiation Phase
The incumbent is responsible for: global essential document development (e.g. study level consent forms, advertising materials), and study deviation specifications; assessing global vendor requirements and liaising with appropriate departments on vendor selection; ensuring the development of global enrollment initiatives and budgetary planning; planning clinical study supplies; review and approval of data management plan.
Study Management/Conduct Phase
The incumbent is responsible for: global IMP supply management; study enrollment management/tracking (e.g. contingency planning and implementation); global vendor management; global budgetary management; trial master file management; periodic review of protocol deviations; ongoing review of study data and data cleaning process.
The incumbent will be responsible for: review of CSR shells; review of CSR and assembly of appendices; database lock activities; finalization of the study protocol deviations repository; ensuring that the study close out activities are completed; ensuring all documents are filed in the TMF appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed.
Program Operations Lead
The incumbent is responsible for developing the operational strategy/execution plan for a clinical program and is responsible for all program management aspects of a global clinical program. For all the global program activities, the incumbent will work with the OSLs and CTMs to ensure the global program is executed on time and to budget. The incumbent may also be asked to participate as a Global Clinical Trial Representative in cross-functional teams such as Protocol Review Team, Case Report Form Review Team, Clinical Study Report Review Team, and the Medical Safety Monitoring Plan Review Team. If a Corrective and Preventive Action is put in place, the incumbent may be asked to serve as the CAPA Lead.
This includes but is not limited to: leading the Clinical Trial Team and sitting on the Project Core Team as required.; project wide clinical budgetary oversight; project feasibility and strategy for study(s) placement; project level inspection readiness; project level tracking and information management; project level clinical supply forecast and oversight.
Leadership and People Development
- May provide leadership and direction to operations teams locally and/or globally.
- Could deputize for their Director when required.
- Assists Director to allocate resources based upon employee development needs, study staffing needs and other business requirements.
- May manage study managers.
- Ensures staff are developed for optimal performance and are trained on SOPs, policies, processes and regulatory requirements.
- Provides timely feedback, coaching and counselling in partnership with Human Resources to ensure staff are performing their responsibilities at the most optimal level.
- Promptly deals with performance issues to minimize disruptions. Participates in all relevant and required SOP and in-house training seminars.
- Is responsible for ensuring that all direct reports training is current for therapeutic area, SOPs, GCP and local clinical research guidelines/laws
- Is responsible for the development plans for direct line reports
- Provides timely communication to staff members on all relevant matters, provides leadership to minimize distractions and disruptions.
- Ensures all performance evaluations are conducted in a timely manner.
Global Brand R&D staff
The employee is responsible for completing all required training to execute their job and maintain their training records. They are responsible for reporting any potential GCP violations either internally or externally to their manager and participate in any corrective and preventative action plans as appropriate. They are responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events. In addition, the employee is responsible for documenting key communications from either internal or external sources in the study file.
General Compliance and Other roles
The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as company policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected to maintain a solid knowledge base for performing assigned tasks.
Other roles may be allocated as appropriate to the incumbent as required to ensure delivery of the clinical studies.
- Significant experience in Pharmaceutical / Medical Device development and people management
- Early and late phase, and therapy area experience is an advantage
- Ability to travel up to 30% of time
- Demonstrated understanding of risks to CROs' businesses and how they might be impacted by the company.
- Ophthalmology experience is a plus.
- Thorough understanding of ICH Good Clinical Practices, global clinical trial management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas.
- Knowledge of scientific methods, research design, and medical practices and procedures that would be acquired through experience with human medical research studies
- Good understanding of drug development process, including preclinical.
- Science Degree (or health-related field) or higher degree
Keywords: Cameron Craig Group, Irvine , Assoc Dir, Clinical Trial Management, Healthcare , Irvine, California
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