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Job Details

Senior Manager, Clinical Operations

Company: Clintec
Location:
Reference: SCPM-UK-0407-DH
Closing Date: 10 Jan 19
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Clintec is currently looking to hire a Senior Manager of Clinical Operations to work at our client's site in Hatfield on a full time, permanent basis. This is an excellent opportunity for a Senior Project Manager with a background in Neuroscience to join a global organisation.. Apply now to become part of our global team!

Requirements:

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


Communication
• 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


Compliance
• 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.

Apply for this job: Senior Manager, Clinical Operations

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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