Clinical Trial Operations Specialist

2 weeks ago

Bracknell Berkshire, United Kingdom Boehringer Ingelheim Full time

CLINICAL TRIAL OPERATIONS SPECIALIST

12 Months Contract

OUR COMPANY

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; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative, and inclusive culture.

THE POSITION

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.

TASKS & RESPONSIBILITIES

· 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.

· Collaborates and interacts with other core and extended trial team members, country level functions (e.g. CTM) and interface functions (e. g. Clinical Trial Supplies Unit, Sourcing, Legal). Smooth cooperation with external functions (e. g. Clinical Research Organisations, vendors, advisors, investigators) to support the conduct of clinical trials.

· Independently manages the set up and maintenance of technical internal and external systems, tracking tools and reports, under the leadership of the CTL.

· Oversees the preparation, compilation, maintenance and distribution of trial level documents. Performs appropriate quality checks on trial level documents. Ensures timely, complete and compliant archiving in the TMF.

· 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)

REQUIREMENTS

· 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).

· Strong communication skills.

· Confident user of electronic applications (Word, Excel, Powerpoint).

  • Clinical Trial Operations Specialist

    2 weeks ago

    Bracknell, Berkshire, United Kingdom Boehringer Ingelheim Full time

    CLINICAL TRIAL OPERATIONS SPECIALIST 12 Months Contract OUR COMPANY 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...

  • Clinical Trial Operations Specialist

    2 weeks ago

    Bracknell, Berkshire, United Kingdom Boehringer Ingelheim Full time

    Job Description CLINICAL TRIAL OPERATIONS SPECIALIST 12 Months Contract OUR COMPANY 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...

  • Clinical Trial Operations Specialist

    2 weeks ago

    Bracknell, United Kingdom Boehringer Ingelheim Full time

    CLINICAL TRIAL OPERATIONS SPECIALIST12 Months Contract OUR COMPANYAt 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...

  • Clinical Trial Operations Specialist

    2 weeks ago

    Bracknell, United Kingdom Boehringer Ingelheim Full time

    CLINICAL TRIAL OPERATIONS SPECIALIST12 Months Contract OUR COMPANYAt 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...

  • Operations Specialist

    1 month 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...

  • Clinical Trial Specialist

    4 hours ago

    Maidenhead, Berkshire, United Kingdom Consult Full time

    Maidenhead Do not pass up this chance, apply quickly if your experience and skills match what is in the following description. Very competitive salary Hybrid working 2x a week Initial 12 month contract which is likely to be extended This is an excellent opportunity for an experienced CTS Coordinator to join a global pharmaceutical company for an initial 12...

  • Clinical Trial Specialist

    7 days ago

    Maidenhead, Berkshire, United Kingdom Consult Full time

    Maidenhead Very competitive salary Hybrid working 2x a week Initial 12 month contract which is likely to be extended This is an excellent opportunity for an experienced CTS Coordinator to join a global pharmaceutical company for an initial 12 months, with the potential for this to be extended. This role has come about due to expansion and an increase in...

  • Clinical Trial Specialist

    7 days ago

    Maidenhead, Berkshire, United Kingdom Consult Full time

    Maidenhead Very competitive salary Hybrid working 2x a week Initial 12 month contract which is likely to be extended This is an excellent opportunity for an experienced CTS Coordinator to join a global pharmaceutical company for an initial 12 months, with the potential for this to be extended. This role has come about due to expansion and an increase in...

  • Clinical Trial Manager

    2 hours ago

    Maidenhead, Berkshire, United Kingdom Consult Full time

    CTS Manager Before applying for this role, please read the following information about this opportunity found below. Maidenhead Very competitive salary Hybrid working 2x a week Initial 12 month contract which is likely to be extended This is an excellent opportunity for an experienced CTS Manager to join a global pharmaceutical company for an initial 12...

  • Clinical Trial Manager

    7 days ago

    Maidenhead, Berkshire, United Kingdom Consult Full time

    CTS Manager Maidenhead Very competitive salary Hybrid working 2x a week Initial 12 month contract which is likely to be extended This is an excellent opportunity for an experienced CTS Manager to join a global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and an...

  • Clinical Trial Manager

    7 days ago

    Maidenhead, Berkshire, United Kingdom Consult Full time

    CTS Manager Maidenhead Very competitive salary Hybrid working 2x a week Initial 12 month contract which is likely to be extended This is an excellent opportunity for an experienced CTS Manager to join a global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and an...

  • Regulatory Affairs Manager

    1 week ago

    Maidenhead, Berkshire, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead. Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified geographic...

  • Manager, Clinical Trial Strategy

    4 weeks ago

    Maidenhead, Berkshire, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead or remotely. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds...

  • Manager, Clinical Trial Strategy

    4 weeks ago

    Maidenhead, Berkshire, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead or remotely. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds...

  • Clinical Trial Manager

    3 weeks ago

    Maidenhead, Berkshire, United Kingdom Consult Full time

    Very competitive salary Hybrid working 2x a week Initial 12 month contract which is likely to be extended This is an excellent opportunity for an experienced CTS Manager to join a global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and an increase in the...

  • Clinical Trial Project Manager

    5 days ago

    Reading, Berkshire, United Kingdom ICON Full time

    Clinical Trial Manager position, UK based – In Vitro Diagnostics/Medical Devices You will be partnering with a well-known leader in in vitro diagnostics, who offer a broad range of innovative ways for hospitals, labs, blood banks and clinics to diagnose and monitor health conditions with greater accuracy, speed, convenience and cost-efficiency. The...

  • Regulatory Manager, Clinical Trials Regulatory Management

    3 weeks ago

    Reading, Berkshire, United Kingdom IQVIA LLC Full time

    Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA page is loaded Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA Apply locations Reading, Berkshire, United Kingdom Solna, Sweden Amsterdam, Netherlands Barcelona, Spain Sofia, Bulgaria time type Full time posted on Posted 7 Days Ago job requisition id...

  • Regulatory Manager, Clinical Trial Strategy

    1 week ago

    Maidenhead, Berkshire, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Regulatory Manager, Clinical Trial Strategy

    3 weeks ago

    Maidenhead, Berkshire, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Clinical Trial Manager

    1 month ago

    Reading, Berkshire, United Kingdom IQVIA Argentina Full time

    IQVIA’s cFSP team are seeking a Clinical Trial Manager to join us on our mission to drive healthcare forward. Great opportunity to shape local component of global study (UK remit / 2 studies across 8-10 sites / phase I-III). Sponsor dedicated to one of the world’s largest pharmaceutical companies. Fully remote with minimal travel. RESPONSIBILITIES ...