Closing Date: 20 Nov 16
Salary (£): Competitive
Benefits: Full Corporate Benefits package + Car Allowance + Bonus
Top Global Pharma
Innovative, ethical and supportive working environment
Excellent transport links and onsite parking
12 month FTC with the possibility of extension
The Senior Manager Clinical Operations will be responsible for:
Management of clinical CRO and technical vendors and ensures that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and company standard operating procedures.
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
•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 company’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
•Collects and reviews key monitoring processes to be benchmarked, tracked and analyzed
•Participates in cross-functional process improvement projects
•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
•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
•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
QUALIFICATIONS / EXPERIENCE REQUIRED:
Prior experience as a Clinical Study Manager
Proven track record of leading cross-functional teams, people coordination, mentoring of junior colleagues.
Experience Neuroscience indications and especially Alzheimers disease preferable but not essential
Exp in budget management
Experience of CRO and technical vendor management essential to ensure delivery of complex multi-national outsourced studies to time and budget.
Full understanding of current ICH/GCP guidelines.
For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please send your CV to email@example.com quoting reference PW-6722.
Only candidates with EU work authorisation will be considered.
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AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
Visit us at www.axess.co.uk
12 Union Court,
Richmond upon Thames,
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