Summary Of Key Responsibilities
* Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
* Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies
* Provide input into global subject/patient recruitment plans.
* Relationship management between study sites and vendors
* Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight.
* Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.
* Create and update critical trial-specific documents (for example country specific ICF) and plans
* Support development of compound and protocol level training materials
* Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
* Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
* Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level
* Participate in process improvement activities at a trial and department level as needed
* Support onboarding of new team members
* Attend CTWG and provide input and updates on operational activities and progress
* Ability to travel (approximately10% but flexibility to go over or below as per business need.
Qualifications
* BS/ BA Degree is required.
* 5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials.
* 2-3+ years leading aspects of global clinical trials
* Experience working with a CRO
* Strong regulatory knowledge, including Good Clinical Practices (GCPs)
* Strong decision-making, analytical and financial management skills are essential to this position
* Proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
* Experience in leading without authority and in multifunctional matrixed and global environments
* Experience mentoring/ coaching others
* Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
* Strong project planning/ management, communication (written and verbal) and presentation skills
* Experience with protocol, ICF, CRF, CSR development and review.
* Proficient with MS Office Suite (Excel, Word and PowerPoint)
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