Manager, Clinical Operations - FSP

Parexel•Southport, NC

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Summary The Manager, Clinical Operations is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery. This includes alignment on the feasibility strategy, target setting, risk reviews, and country challenges that could impact overall study delivery.

Requirements

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)

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