Senior Manager, Clinical Operations

26 Oct 2018
12 Feb 2019
Clinical Research
Contract Type

Main areas of responsibility include:

Complexity / Innovation
• Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures
• Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
• Called upon to develop solutions utilizing creativity and ingenuity

• Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues
• Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity

Supervision Given / Received
• Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees
• Work is completed under limited supervision
• Typically reports to an Associate Director or above

Clinical Trial Management
• Has primary accountability for operational study level time, cost and quality deliverables
• Manages overall study budget – for large, global or multiple regional studies

Clinical Trial Execution
• Coordinates all operational clinical research activities for regional / global studies
• Manages all aspects of study progress from start-up to close-out activities in accordance with ICH/ GCP guidelines
• Contributes to preparation of teams and documents for inspections

Problem Solving
• Assesses risks and develops creative solutions
• Escalates issues to Unit leadership as appropriate
• Comprehensively assesses options to address study issues

Document Creation and Management
• Supports the timely development and / or review of all study related documents (e.g., PCS, Protocol, CRF etc.) and operational feasibility assessments

CRO / Vendor Management
• Serves as primary interface with CROs to ensure appropriate study/operational strategy is followed
• Selects  / approves monitoring CROs and study sites
• Evaluates vendor proposals against Eisai’s terms and critical needs and partners with internal functions to define scope of work
• Manages CROs for successful conduct of the clinical trial and assesses contractual deliverables

Process Management
• Collects and reviews key monitoring processes to be benchmarked, tracked and analyzed
• Participates in cross-functional process improvement projects

Resource Management
• Enhances the capabilities of current resources (tools, systems, vendors, etc.), technologies, and processes for the team
• May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines

Financial Management
• Resolves expense issues and manages costs of work teams before issues arise
• Manages team finances in compliance with financial standards and guidelines
• Assists the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalate issues when appropriate

Matrix and Team Management
• Provides feedback, sets clear tasks and objectives and coaches team members on a periodic basis
• May support employees by providing input into recruitment, selection, performance, succession, and transition activities
• Trains team members on processes and / or systems

People Management (if assigned direct reports)
• Manages individual contributors
• Assists or Leads training of junior staff

• Complies with all applicable laws / regulations of each country in which we do business
• Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or Physicians
• Reports legal, compliance and ethical violations in a timely manner


Experience & Qualifications:
BS/MS in relevant field


Company Information:

Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

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