Pre-clinical Study Manager

2 weeks ago


London, United Kingdom Hyper Recruitment Solutions Ltd Full time

HRS are currently looking for a Pre-Clinical Study Manager / Associate Director to join a leading Biotherapeutics company based in the London area. As the Pre-Clinical Study Manager / Associate Director you will be responsible for overseeing the non-clinicalPK and Toxicology studies and prepare regulatory documentation.
This is an ideal position for an experienced study manager in the biologics fields who is looking for an independent role.
The role offers flexibility working from home.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Pre-Clinical Study Manager / Associate Director will be varied however the key duties and responsibilities are as follows:
1. You will design the PK phase of non-GLP and GLP studies and act as the main point of contact for CRO-based outsourced work.
2. You will be responsible for writing the non-clinical PK module of regulatory documents, including but not limited to IND/BLA/MAA
3. You will use Phoenix WinNonLin for PK/PD modelling (training and support will be provided)
4. You will be responsible for determination of PK parameters and write PK reports. You will closely collaborate with the internal bioanalytical team.
ROLE REQUIREMENTS:
1. Relevant degree in Toxicology, Pharmacokinetics, Pharmacology and more.
2. Proven industry experience in overseeing non GLP & GLP studies focused on biologics.
3. Experience with analysing PK Studies from various species (nonhuman primates, rats etc)
Key Words: PK Study Manager / DMPK / Pharmakokinetics / PK / PD / PK Data / NonClinical Pharmacokinetics / Associate Director / Leader / Small Molecules / Large Molecules / London



  • London, United Kingdom Cpl Life Sciences Full time

    Clinical Study Coordinator 2 month contract £30,000-£37,000 per annum Central London CPL are urgently recruiting for an experienced Clinical Study Coordinator to help support an NHS trust with the organisation of a number of on-going studies. This is a fantastic opportunity to contribute directly to NHS research within a clinical researchfacility and...


  • London, United Kingdom Resourcing Life Science Full time

    Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. Leading cross-functional project teams globally for the assigned studies in start up phase Bachelor degree in life-science Experience in...


  • London, United Kingdom IQVIA Argentina Full time

    Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned...


  • London, United Kingdom Imperial Clinical Trials Unit Full time

    Job Description: We are looking for an expert in clinical trial Data Systems and Data Management to join the UKCRC registered Imperial Clinical Trials Unit (ICTU) team as the new Head of Clinical Data Systems (CDS). Imperial Clinical Trials Unit (ICTU) is a UKCRC-registered clinical trials unit that brings together academic, clinical and trial...


  • London, United Kingdom IQVIA Argentina Full time

    Job Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Essential Functions Oversee the execution of Site Activation (including pre-award/bid defense activities)...


  • London, United Kingdom IQVIA Full time

    Job Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Essential Functions Oversee the execution of Site Activation (including pre-award/bid defense...


  • London, United Kingdom Cpl Life Sciences Full time

    **Reference Number**: JO-2303-512804 Study Start-up Specialist **Rate**: Negotiable **Job Type**: Contract **Location**: Central London / West End Study start-up Specialist 3-month contract London based (3 days on site, 2 days remote) £35,000-£40,000 per annum CPL Life Sciences are actively recruiting for an experienced start-up specialist to join...

  • Clinical Advisor

    4 weeks ago


    London, United Kingdom Medpace Full time

    This role will work side by side with our physicians, serving as clinical expert, to support our project teams in clinical research studies (no direct patient care). Experience in the medical management of patients with these diseases, including prescriptive authority, is preferred. Experience in clinical research is preferred. Review study and study...


  • London, United Kingdom Thornshaw Scientific Recruitment Full time

    Posted date 23 March 2023 - LocationLondon - Job type Temp - SalaryNegotiable - Discipline Life Sciences - ReferenceJO-2303-512804 Study start-up Specialist 3-month contract London based (3 days on site, 2 days remote) £35,000-£40,000 per annum CPL Life Sciences are actively recruiting for an experienced start-up specialist to join a leading Academic...


  • London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

    Job summary An exciting opportunity has arisen for a motivated and organised Research Midwife to join the INSIGHT2 team. Building on our previous pregnancy cohort study (INSIGHT, which focussed on biomarkers for risk prediction of PTB; recruited > 2000 women), the goal of this INSIGHT-2 study is to recruit a larger, more comprehensive longitudinal...


  • London, Greater London, United Kingdom IQVIA Full time

    Clinical Project Manager Sponsor Dedicated, Home Based, UKJoin us on our exciting journeyRemote/Hybrid/Office based working options.Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forwardAs Clinical Project Manager you will be responsible for running local studies in all therapeutic areas, managing the operational...


  • London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

    Job overview An exciting opportunity has arisen for a motivated and organised Research Midwife to join the INSIGHT2 team.  Building on our previous pregnancy cohort study (INSIGHT, which focussed on biomarkers for risk prediction of PTB; recruited > 2000 women), the goal of this INSIGHT-2 study is to recruit a larger, more comprehensive longitudinal...


  • London, United Kingdom Antal International Network Full time

    The CTM role will involve regional management on Phase Ib-III clinical studies, with a strong emphasis on the EMEA region. The successful candidate will be a member of the Global Study team overseen by a Clinical Program Manager. The candidate will likely work across several studies, including involvement from study start-up through study close-out...


  • London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

    Clinical Research Midwife - INSIGHT 2 Study An exciting opportunity has arisen for a motivated and organised Research Midwife to join the INSIGHT2 team. Building on our previous pregnancy cohort study (INSIGHT, which focussed on biomarkers for risk prediction of PTB recruited > 2000 women), the goal of this INSIGHT-2 study is to recruit a larger, more...


  • London, United Kingdom Hays Specialist Recruitment Limited Full time

    Experienced Early Phase Clinical Study Manager 12 month contract remote, good rate (in scope) A Clinical Study Manager is required to join a global pharma on a contract basis. This is a 12 month fully remote position based in the UK. The contract will sit inside IR35. Responsibilities will include: - Lead one or more multi-functional, Clinical Study...


  • London, United Kingdom UNIVERSITY OF THE ARTS Full time

    The Dean will provide academic and managerial leadership for the School of Pre Degree Studies and lead on the strategic development of progression routes into Higher Education, delivering key strands of UAL's strategic commitment to increasing and diversifying access to a creative education and associated change programmes. About you Recognised as a...


  • Uxbridge, Greater London, United Kingdom Collabera Digital Full time

    Manage regional Phase Ib-III clinical studies in the EMEA region. * Draft and coordinate review of study documents like protocols, case report forms, and clinical study reports. * Manage CROs/vendors, coordinate data listings review, and train study personnel. * Work with Clinical Program Managers to manage regional Virology clinical trials. * Require...


  • London, United Kingdom CHR Life Sciences Full time

    CHR Life Sciences is exclusively partnered with a boutique clinical services firm looking to expand. The company, founded in 2015, recently acquired its clinical packaging service license from the MHRA in 2023 and is looking for a supervisor to help build out the function and create a team of operators beneath them. Ensure the quality of packaged clinical...


  • London, United Kingdom Resourcing Life Science Full time

    Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Global Clinical Contract Manager office based in London. Management of the site contract timelines for the...


  • London, United Kingdom Study International Full time

    Full-time Role Type: Hybrid Sales & Business Development Schedule: Full Time Experian is the world’s leading global information services company. We’re passionate about unlocking the power of data in order to transform lives and create opportunities for consumers, businesses and society. For more than 125 years, we’ve helped economies and...