Global Clinical Operations Lead - Oxford, Oxfordshire, United Kingdom - Northreach

Description

THE COMPANYNorthreach is a fast growing and next gen recruitment business set up in 2015, specialising in Biotechnology, IT, Finance and Embedded Talent Acquisition solutions in the UK, USA and Middle East.

We're a growing company that believes in offering outstanding delivery, over and above quality and a consistency which our clients love.

Northreach offer a huge potential for fast-track progression, responsibility and sense of ownership, so we are looking for individuals that want to strive to be the best at what they doWe operate from a modern, fully serviced and spacious office, a stone's throw from Billericay station.

As well as a nifty casual dress code, we work with a smart attitude, supporting one another achieve personal goals and targets.

We are a positive bunch who take real pride in developing our people, celebrating and shouting about our success, internally and externally.

OUR MISSIONTo become the number one, go-to agency in the Biotech and Fintech marketplace. The people we work with describe us as individuals. They say we have a unique personality.

They say we are like-minded, professional, dedicated and delivery focused but above all, they say that we are a pleasure to work with.

My client, is a growing Biotechnology company at the forefront of groundbreaking Cancer Research.

It is an exciting time for the business as they look to take their new indication within autoimmune disease to the clinic and as such are looking to hire a new Global Clinical Operations Leader to help set this up and run the team.

Although senior in title this is very much a hands on role and will be responsible for running the study.

Summary The global/regional Clinical Operations Lead will oversee study execution and provide input as well as operational oversight to CRO partners, leadership, and management of clinical studies.

They will provide local/regional expertise, contribute to the overall operational strategy, and oversee capabilities (internally and externally) required to deliver clinical research.

They will be an experienced and pragmatic innovator that will confidently and persuasively interact with investigators and CRO partners, as well as work independently and proactively within a cross-functional global study team.

Responsibilities:

Lead local/regional study execution activities related to the development of my client's technologies Actively participate in the Study Team to implement and oversee a nimble and efficient operating model for clinical trial activities, working with key internal stakeholders, 3rd party vendors/CROs and establishing appropriate systems and infrastructures to ensure timely and compliant delivery of goals Input into trial design and translate scientific imperative into operational delivery of trials Review protocols, study plans, IP management plans, CSRs and other trial-related documentation Advise regarding the development of IND/Clinical Trial Authorisation (CTA) and ethics committee packages and documentation, in alignment with related objectives and regulatory requirements Partner closely with CRO(s) to build excellent working relationships and communication, and effective quality oversight and documentation Proactively identify risks pertaining to clinical trial execution, providing actionable plans and mitigation strategies Develop and maintain effective relationships with investigators and clinical sites locally, including some site visits where requested Participate in investigator meetings/webinars, coordinating relevant expert and team input locally in conjunction with CRO partner(s) where relevant Provide guidance on protocol and procedures in the development of eCRF design and data management activities In conjunction with global team, review clinical trial data - monitor data quality and ensure appropriate quality measures are in place In collaboration with CRO partner, ensure TMF completion and inspection readiness Assist global team to build local clinical operations capability as needed, in line with the company's growth strategy Ensure compliance with all applicable industry regulatory standards and partner with Quality team to support and maintain a strong quality mindset and culture Assist Head of Clinical Operations with the planning and management of budgets for clinical trial activities in line with the business needs Complete all appropriate GXP/SOP training and adhere to all role specific SOP requirements GXP Requirements:BSc/ PhD in a relevant scientific discipline At least 5 years of clinical research experience in industry (Pharma, biotech or CRO) preferably in Phase 1-3 autoimmune drug development A broad understanding of drug development including CMC, Regulatory, Safety and non-clinical activities.

Demonstrated track record of clinical trial delivery across the product lifecycle but strong preference for candidates with early clinical development experience Experience of successfully leading trial site and CRO interactions Proven capability to innovate and guide trial activities where pathway is not well defined and bespoke solutions are required Experience in a fast-paced, entrepreneurial, high-growth environment.

Be comfortable assimilating sometimes ambiguous information and comfortable working on high-risk programmes Excellent communication skills both verbally and written; flexibility to adapt to communicating across all stakeholder groups.

Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age.

We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with businesses that promote DEI.

We strive to create a welcoming and inclusive environment for all employees.