Clinical Project Associate

2 weeks ago

Reading, United Kingdom ICON Full time

As a Clinical Project Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The CPA will interact on a global scale within the study team and clinical team. The CPA sphere of influence and communication will include the Global Clinical Lead, the Clinical Project Manager, the Study Manager(s), the Study Lead Monitor(s), Study Data Manager, Study Medical Expert, Study Statistician, country teams, the IxRS & Medication Manager (IMM), Legal, Procurement, Regulatory Affairs, Controlling, Accounting, Pharmacovigilance, Insurance and other study team members (globally and locally). The CPA will additionally liaise with external suppliers globally.
- Support global study team by completing delegated study tasks.
- Coordinate administrative tasks and logistic support throughout the study, audit and regulatoryinspections according to company policy and SOPs.
- Coordinate project and/or study material preparation and study communication internally and/or with external vendors such as:
Manage and maintain study information and documents as agreed with study team.Set-up and maintain study specific working areas and internet-based forums, support Recruitment and Retention team in preparing external study websites, social media channels etc.

Create and send communication materials to country teams (e.g., Newsletters, study document updates).

Coordinate communication of project/study status to various levels of management

Coordinate investigator and CRA training material preparation activities, provide technical support, ensure delivery of training materials in due time, make material available.

Manage vendor system access (user account) activities for internal and external users. Ensure account creation during study start-up and conduct, conduct periodic checks of valid user accounts, and ensure deactivation of unnecessary user accounts.
- Coordinate logistics (orders and shipments) of trial supplies for sites (e.g. eCOA device orders and shipments, laboratory kits and medical equipment).
- In cooperation with other global study team members prepare essential clinical trial documentation and distribute to countries.
- Obtain study insurance documentation for different countries at the study start and maintain insurance documentation during the study, communicate with insurance group (for internal and outsourced studies) as delegated by StM
- Collect essential documents as needed.
- Maintain operational tracking and reporting systems and tools; for example, YourDOCs (invoices), IRIS (study level issue&action tracking), Veeva Vault Clinical/IMPACT, Veeva eTMF, CART, external vendor systems etc.
- Have oversight of site, country and study level CTMS entries.
- Track study progress and run progress reports for StM/SLM through following up with other team members and develop update reports for StM/SLM.
- Run oversight reports related to outsourced studies.
- Lead the practical arrangements coordination of internal and external meetings (scheduling, drafting agenda and/or presentations, taking care of practical arrangements, writing meeting minutes and tracking action items) for the Clinical Team and Study Team kick-off meetings, study Start-up Camp, kick-off meetings with external vendors, Clinical Team meetings, global core Study Team meetings, Country Calls arranged by SLMs as well as global and regional investigator meetings and global/regional monitor training meetings in collaboration with IMEX group (if applicable) and advisory committee meetings as requested by CPM/GCL.
- Ensure the availability, quality, and completeness of the clinical study documents in the Trial Master File to enable final compilation of the documents for marketing authorization submissions of new medications and medical devices.
- Upload and maintain global documentation in eTMF (e.g. meeting minutes, eCOA documentation).
- Coordinate the functional (global) milestone related quality and completeness check review of eTMF.
- Run oversight reports and do random spot checks for eTMF completeness and quality.
- Act as a point of contact for SSU/QC Specialists, CLMs and global core Study Team members for study specific eTMF filing issues.
- Support outsourced studies under COSMOS as interface between Medical Affairs, CRO and Resource Management.
- Contribute to departmental / company initiatives and special projects. Provide expertise and support project planning, project management and implementation of functional initiatives to improve processes.
- Bachelor’s degree or equivalent relevant experience
- Experience in the healthcare field, pharmaceutical industry or clinical research / development or administrative activities.

**Why ICON?**

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our

  • Experienced Clinical Research Associate

    Found in: Talent UK C2 - 1 week ago

    Reading, United Kingdom IQVIA Full time

    Clinical Research Associate (all levels) Sponsor Dedicated, Home Based, UK Join us on our exciting journey! Remote/Hybrid/Office based working options. Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward! As Clinical Research Associate you will be responsible perform monitoring and site management work...

  • Experienced Clinical Research Associate

    Found in: Talent UK C2 - 3 days ago

    Reading, United Kingdom IQVIA Full time

    Clinical Research Associate (all levels) Sponsor Dedicated, Home Based, UK Join us on our exciting journey! Remote/Hybrid/Office based working options. Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward! As Clinical Research Associate you will be responsible perform monitoring and site management work...

  • Data Protection Associate

    Found in: Whatjobs ES C2 - 5 days ago

    Reading, United Kingdom Project People Full time

    Data Protection AssociateGlasgow or Reading Hybrid working (2 days/week in office)06 months contract As part of the Data Protection team, the Data Protection Associate will provide support to facilitate client's compliance framework, including policies, processes, procedures and controls, in place to operate in line with its legal and regulatory obligations...

  • Data Protection Associate

    5 days ago

    Reading, United Kingdom Project People Full time

    **Data Protection Associate** **Glasgow or Reading** **Hybrid working (2 days/week in office)** **06 months contract** As part of the Data Protection team, the Data Protection Associate will provide support to facilitate client's compliance framework, including policies, processes, procedures and controls, in place to operate in line with its legal and...

  • Data Protection Associate

    1 week ago

    Reading, United Kingdom Project People Full time

    Data Protection Associate / DSAR Specialist - required for leading mobile telecoms company. Role can be based in Reading or Glasgow. Hybrid working - 2 days/week in the office DPA Data Protection Associate with strong DSARs experience - asap start - 6 month contract Company Description As part of the Data Protection team, the Data Protection...

  • Data Protection Associate

    Found in: Whatjobs ES C2 - 1 week ago

    Reading, United Kingdom Project People Full time

    Data Protection Associate / DSAR Specialist - required for leading mobile telecoms company. Role can be based in Reading or Glasgow. Hybrid working - 2 days/week in the office DPA Data Protection Associate with strong DSARs experience - asap start - 6 month contract Company DescriptionAs part of the Data Protection team, the Data Protection Associate will...

  • Clinical Research Associate

    4 days ago

    Reading, Berkshire, United Kingdom IQVIA Argentina Full time

    Clinical Research Associate (all levels) Sponsor Dedicated, Home Based, UK Remote/Hybrid/Office based working options. Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward! As Clinical Research Associate you will be responsible perform monitoring and site management work to ensure that sites are conducting...

  • Clinical Trial Project Manager

    4 days 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. Partner with...

  • Associate Director of Nursing

    4 days ago

    Reading, United Kingdom Royal Berkshire NHS Foundation Trust Full time

    An exciting opportunity has arisen to join the Quality Governance Team at the Royal Berkshire Hospital NHS Foundation Trust As an Associate Director of Nursing you will provide support to the Associate Chief Nurse and Chief Nurse. The post holder will have a senior leadership role, working closely with the Associate Chief Nurse and Chief Nurse, Directors,...

  • Senior Clinical Research Associate

    3 weeks ago

    Reading, Berkshire, United Kingdom IQVIA Full time

    join us on our mission to drive healthcare forward! We are recruiting for a Senior Clinical Research Associate to assist our sponsor’s Early Development team (phase 1). This is a fully remote position (open to candidates anywhere in the UK) with travel to sites. Professional development - resources that promote your career growth and programs to help...

  • Experienced Clinical Research Associate

    Found in: Talent UK C2 - 2 weeks ago

    Reading, United Kingdom IQVIA Full time

    Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward! Why IQVIA? Growth potential - clear pathways to success for those who want to grow with us Professional development - resources that promote your career growth and programs to help you build knowledge and gain skills Work-life balance - leaders that...

  • Data Protection Associate

    5 days ago

    Reading, Berkshire, United Kingdom Project People Full time

    Data Protection Associate / DSAR Specialist - required for leading mobile telecoms company. Role can be based in Reading or Glasgow. Hybrid working - 2 days/week in the office DPA Data Protection Associate with strong DSARs experience - asap start - 6 month contract Company Description As part of the Data Protection team, the Data Protection Associate...

  • Clinical Trial Manager

    Found in: beBee jobs GB - 1 week ago

    Reading, Reading, United Kingdom IQVIA 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 Partner...

  • Clinical Trial Manager

    3 weeks ago

    Reading, Berkshire, United Kingdom IQVIA Argentina Full time

    IQVIA’s cFSP (sponsor-dedicated) team are seeking a Clinical Trial Manager to join us on our mission to drive healthcare forward. The Clinical Trial Manager will partner with the Clinical Trial Assistants, Clinical Research Associates, Central Trial Managers and Global Trial Managers to ensure overall study delivery at country level. Partner with...

  • Clinical Trial Manager

    3 weeks ago

    Reading, Berkshire, United Kingdom IQVIA Argentina Full time

    IQVIA’s cFSP (sponsor-dedicated) team are seeking a Clinical Trial Manager to join us on our mission to drive healthcare forward. The Clinical Trial Manager will partner with the Clinical Trial Assistants, Clinical Research Associates, Central Trial Managers and Global Trial Managers to ensure overall study delivery at country level. RESPONSIBILITIES ...

  • Clinical Trial Manager

    Found in: Talent UK C2 - 1 week ago

    Reading, United Kingdom IQVIA 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 ...

  • Senior Clinical Transformation Manager

    7 days ago

    Reading, Berkshire, United Kingdom Royal Berkshire NHS Foundation Trust Full time

    An exciting opportunity has arisen for a fixed term 2 year role as a senior clinician with systems implementation experience, this role is to provide a bridge between clinical stakeholders and colleagues within the DDaT project team(s). As the intermediary, this role will provide clinical insight to the project team and validate the proposals impacting...

  • Associate Manager, Clinical Trials Regulatory Management

    7 days ago

    Reading, Berkshire, United Kingdom IQVIA LLC Full time

    Associate Manager, Clinical Trials Regulatory Management (m/w/d) - Home-based, Europe page is loaded Associate Manager, Clinical Trials Regulatory Management (m/w/d) - Home-based, Europe Apply locations Reading, Berkshire, United Kingdom Belgrade, Serbia Solna, Sweden Vienna, Austria Warsaw, Poland time type Full time posted on Posted 7 Days Ago job...

  • Clinical Teaching Fellow in Paediatrics

    Found in: Talent UK C2 - 2 weeks ago

    Reading, United Kingdom Royal Berkshire NHS Foundation Trust Full time

    Job summary This 12 month post is an excellent opportunity for candidates to work as a Clinical Teaching Fellow in Medical Education (40%) whilst gaining clinical experience in Paediatrics (60%). All training will take place at the Royal Berkshire Hospital. The Royal Berkshire Hospital hosts students from both the University of Oxford and the...

  • Projects Senior Associate/Associate Director

    3 weeks ago

    Reading, Berkshire, United Kingdom IQVIA Argentina Full time

    The Senior Study Leader is the leader of the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve objectives. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. guides planning and decision making...