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With over 60 years of global experience, Wickham Micro Limited are a world leader in providing contract microbiology services to the pharmaceutical and medical device industry; ensuring the products we test are safe and effective for their intended use.
Role
We are currently seeking a Study Manager to start in our laboratory at Wickham Micro Ltd. The postholder for this role will be responsible for overseeing GMP, GLP and R&D projects within the organisation for our external clients.
Main Responsibilities
* The timely delivery of client projects adhering to all regulations.
* To ensure the seamless initiation and delivery of client projects within budget, working with the teams and clients to ensure 360 degree communication throughout the lifecycle.
* To oversee project budgets ensuring oversight of additional work or out of scope requests are charged accordingly.
* To be a direct link between the Business Development Team and the Laboratory Managers for each project.
* To manage an allocation of clients within the Study Managers team and provide cover for other clients during periods of annual leave and absence within the team.
* To ensure all work is carried out by the laboratories in line with the agreed methods to obtain accurate results and to feedback to relevant internal parties of any circumstances that may jeopardise the integrity of results.
* To ensure all data is collated, reviewed and approved for collation of reports and compliance with quality procedures.
* To ensure the teams prepare protocols, reports and other standard laboratory documentation (such as non-conformance reports, change controls and risk assessments) in compliance with company procedures.
* Problem solving where necessary; applying acquired expertise to analyse and solve problems including those without clear precedent. Identify root cause and appropriate actions, contributing ideas and suggestions to improve current process.
* To act as Study Director on selected GLP studies (Multi site studies - Biocompatibility).
* To work in compliance with GLP, GMP and the general and Health and Safety policies and procedures of Wickham Micro Quality System.
* To undertake work as directed by the Laboratory Manager, Senior Business Manager or General Manager, including cross-training between areas of work as far as reasonably practicable.
* Ensure that service is delivered to the highest standard, meeting GMP, compliance and regulatory standards.
* Ensure all data is collated, reviewed and approved for preparation of reports as well as conducting authorisation of data.
* To identify opportunities for additional work with clients and to liaise with BD on such matters.
* To be the single point of contact within the operations team for their clients.
Key Skills
* Solid organisational skills.
* Great communication skills both written and verbal.
* Proactive.
* Good influencer and negotiator.
* Can work autonomously.
Experience
Ideally has previous experience either working in a laboratory or a science based discipline. This would be a great opportunity for someone to develop their career who has previously been in the role of a scientist, within a commercial organisation or a researcher within a university or a clinical/hospital background.
Human Skills:
We value individuals who embody the following qualities:
* Integrity, Meticulousness, Competence, Respect.
* Reliability, Motivation, Accountability.
* Collaboration, Partnership, Listening, Responsiveness.
* Efficiency, Positivity, Adaptability, Lean Thinking.
* Respect, Patience, Supportiveness, Fun.
Our Company is a great place to work, and we want you to enjoy working with us.
Here's what we can offer you:
* 20 days' holiday plus bank holidays.
* Option to purchase up to 3 additional days' holiday each year.
* Occupational sick pay scheme.
* Auto-enrolment into our Pension scheme.
* Cycle to Work scheme.
* Health and wellbeing support through our Employee Assistance Programme.
* Plenty of free on-site parking.
* Free tea, coffee, hot chocolate and fresh fruit.
* Option to be part of our Medical Cashback Scheme allowing you to claim back on things such as dentist fees, opticians, physiotherapy, counselling and much more.
* Digital Doctor.
* Life assurance.
* Company events from 'Summer Shindigs' to the occasional visit from the ice cream van for a lunch time treat!
* The opportunity to be part of an experienced team that is constantly evolving with the Company.
Applications will only be accepted from individuals who are eligible to live and work within the UK.
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