Operations Specialist

4 weeks ago


Bracknell Berkshire, United Kingdom Boehringer Ingelheim Full time

CLINICAL TRIAL OPERATIONS SPECIALIST
12 Months Contract

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; We are currently recruiting for a contract Clinical Trial Operations Specialist (CTOS) position to join our UK Clinical Development and Operations (CD&O) team.

As a CTOS, you are responsible for supporting the Clinical Trial Leader (CTL) in coordination around planning, set-up, conduct, closeout and reporting of your assigned trials, according to ICH GCP, BI standard operating procedures and applicable regulatory / ethical guidance.

The CTOS is expected to take initiative and work independently on assigned tasks, but in close collaboration with the CTL and other extended trial team members (e.g. regional Clinical Trial Managers (CTMs)), in addition to external functions (e.g. Clinical Research Organisations, advisors, vendors), to support the seamless and timely delivery of clinical trials.

The CTOS is accountable for supporting the oversight of trial supplies, documentation, submissions, co-ordination of communication, and the management of complex technical systems to manage clinical trials.

Administers and co-ordinates information for the planning, co-ordination and conduct of trial activities in accordance with ICH-GCP and defined timelines, in close communication with, and under the leadership of, the CTL.
· Clinical Trial Supplies Unit, Sourcing, Legal). Clinical Research Organisations, vendors, advisors, investigators) to support the conduct of clinical trials.

· Performs appropriate quality checks on trial level documents. Keeps overview of records to address local regulatory demands from Ethics / Authorities to support timely submission and resubmissions.

· Coordinates activities related to the preparation of the Clinical Trial Report (CTR)

University degree or comparable professional education, or relevant experience in the area of clinical trials.
· Previous experience working in administrative management of clinical trials in an international context and in-depth understanding of corporate culture and cross-culture dynamics.
· Good knowledge of ICH-GCP and understanding of major regulatory requirements (US FDA, EMA and PMDA).
· Confident user of electronic applications (Word, Excel, Powerpoint).



  • Bracknell, Berkshire, United Kingdom Adecco Full time

    Adecco are recruiting for a Legal Adviser for one of their clients to start as soon as possible. Work with and support of members of the Global and European members of the Legal Department in achieving their objectives in a resource-efficient manner by providing high-quality, proactive, objective and commercially orientated legal advice. Prepare, edit,...

  • Operation specialist

    4 weeks ago


    Reading, Berkshire, United Kingdom Workingmums Full time

    For nearly 70 years, AWE has been at the forefront of nuclear weapons research and development. We also use our unique skills to provide wider UK government with counter-terrorism and nuclear threat reduction solutions. AWE’s Nuclear Threat Reduction (NTR) Operations Team are currently looking for NTR Specialists to contribute to our dynamic, fast-paced...


  • Bracknell, Berkshire, United Kingdom Marc Daniels Specialist Recruitment Ltd Full time

    A well known automotive company are looking to recruit a Finance Systems Manager to take ownership of all of their financial systems and Masterdata and establish a team of SMEs. This is a fantastic time to join a large established business that offers excellent exposure and a brilliant opportunity to make your mark and influence change. This business...


  • Bracknell, United Kingdom Honda Full time

    **Date**:30 Oct 2023 **Location**: Bracknell, GB **Company**:Honda Motor Europe Ltd At Honda we embrace inclusion in our various policies, so whilst our contracts state that the hours are as required to fulfil the role with a minimum of 35 hours per week, we offer flexibility for when you work. The regular office hours are 08:00 - 16:00 Monday to Thursday...


  • Slough, Berkshire, United Kingdom Marc Daniels Specialist Recruitment Ltd Full time

    A fantastic role has arisen for an Accounts Payable Specialist to join an established Internationally successful company based in Slough. This is a full-time office-based role offering full training and support. Responsibilities: * Coding, posting and attaching Purchase Invoices and staff expenses, ensuring the purchase order (PO) process has been...


  • Newbury, Berkshire, United Kingdom Baxter Healthcare Full time

    At Baxter, we are deeply connected by our mission. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Sales Operations Specialist We are seeking a highly organized and meticulous Sales Operations...


  • Bracknell, Berkshire, United Kingdom Appogee HR Full time

    Job Description Appogee HR are seeking a Customer Experience Specialist to join our Customer Success team in Bracknell, Berkshire. The successful candidate will be an excellent communicator and relationship builder who is able to provide outstanding customer service to Appogee HR customers. Our Customer Success team’s main focus is to provide the best...


  • Bracknell, United Kingdom Butler Ross Full time

    **Customs and Trade Compliance Specialist** A fantastic opportunity for a **Customs and Trade Compliance Specialist** to join a constantly growing chemical manufacturing company based in **Bracknell**. The Customs and Trade Compliance Specialist will support the regional logistics team in their day-to-day operations regarding customs topics with...


  • Berkshire, United Kingdom AWE PLC Full time

    As we move into an exciting phase in our programme, we have an opportunity for **Business Operations Engagement Specialist** at the start of their career to join AWE. Location: Reading /Basingstoke area **Salary**: £32,950 per annum Closing Date: 5th January 2023 AWE **(one of the best 25 big companies to work for in the UK)** offers an attractive array...

  • Head of Operations

    3 weeks ago


    Bracknell, United Kingdom Pod Talent Ltd Full time

    I am excited to be partnering with a fast-growing medical devices manufacturer, who has already established themselves on an international scale and are looking for an experienced Head of Operations to join their team, and take their operations to the new heights. They have already built a robust e-commerce presence, whilst also continuing to expand within...


  • Bracknell, United Kingdom Pod Talent Ltd Full time

    Pod Talent is happy to be partnering with a fantastic consumer goods company, which has been operating for more than a hundred years on an international scale and promotes a great people-first culture with fantastic career development opportunities. Our client is looking to add a B2B Order Management Specialist German Speaker (remote) to their customer...


  • Bracknell, United Kingdom Pod Talent Ltd Full time

    Pod Talent is happy to be partnering with a fantastic consumer goods company, which has been operating for more than a hundred years on an international scale and promotes a great people-first culture with fantastic career development opportunities. Our client is looking to add a B2B Order Management Specialist German Speaker (remote) to their customer...


  • Bracknell, United Kingdom Marc Daniels Specialist Recruitment Ltd Full time

    A well known automotive company are looking to recruit a Finance Systems Manager to take ownership of all of their financial systems and Masterdata and establish a team of SMEs. This is a fantastic time to join a large established business that offers excellent exposure and a brilliant opportunity to make your mark and influence change. This...


  • Bracknell, United Kingdom Pod Talent Ltd Full time

    Pod Talent is happy to be partnering with a fantastic consumer goods company, which has been operating for more than a hundred years on an international scale and promotes a great people-first culture with fantastic career development opportunities. Our client is looking to add a B2B Order Management Specialist German Speaker (remote) to their customer...


  • Bracknell, Berkshire, United Kingdom JAM IT Consultancy Ltd Full time

    Motivate immediate team on a daily basis to deliver across their key areas of responsibility. Respond to and assist team members to resolve escalations or technical questions. Monitor the performance of the immediate team and support them to make improvements as necessary. Be involved in recruitment process for new team members. Regularly meet with team...


  • Bracknell, Berkshire, United Kingdom Dynamite Recruitment Solutions Ltd Full time

    Customer Relations Manager/Complaints Manager Hybrid – 2 days in the office and 3 at home. The duties of the Customer Relations Manager/Complaints Manager will be: Managing a small, specialist team that oversee complaints resolution. Handle escalated complaints with professionalism, implementing the highest standard of customer...


  • Maidenhead, Berkshire, United Kingdom SRG Full time

    SRG are currently looking for Regulatory Specialist for a Global Pharmaceutical Company who have opened new vacancies within their Regulatory team on an initial 12 Month basis to be based at their office in Maidenhead/Remote. The Regulatory Specialist is responsible for providing global regulatory expertise for Clinical Trials. They are the primary...


  • Bracknell, Berkshire, United Kingdom Dynamite Recruitment Full time

    Customer Relations Manager/Complaints Manager Hybrid - 2 days in the office and 3 at home. The duties of the Customer Relations Manager/Complaints Manager will be: Managing a small, specialist team that oversee complaints resolution. Handle escalated complaints with professionalism, implementing the highest standard of customer service. Use...

  • Marketing Specialist

    4 weeks ago


    Bracknell, United Kingdom Allegis Global Solutions Full time

    Company Description At Allegis Global Solutions each of us is here to create real, measurable impact that moves needles. We operate beyond “roles” or “jobs” to realize the opportunity to make meaningful contributions to a bigger idea. We're here to design workforces that unleash the most transformative power in business today: The power of human...

  • Commercial Specialist

    2 weeks ago


    Berkshire, United Kingdom AWE PLC Full time

    AWE are looking to recruit a Commercial Specialist to provide support to the commercial team, in the operation and implementation of commercial processes. **Location**:Reading area **Salary**: £33,350 - £50,000 based on experience AWE **(one of the best 25 big companies to work for in the UK)** offers an attractive array of benefits which include: -...