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Job vacancies

  • Clinical Project Manager

    We are looking for a Clinical Project Manager within our organisation.

    Role Overview 

    • Responsibility for all clinical project activities in relation to assigned clinical studies. This will include start-up activities, patient recruitment, data processing and closure of the clinical study;
    • Managing the clinical trial;
    • Ensuring all trials deliverables are met according to timelines, operational procedures and quality standards as per GCP;
    • Training CRAs on clinical management and potential issues;
    • If necessary, performing  on site monitoring activities involved in the trial;
    • Responsibility of the financial management of the clinical trial, including budget planning, resources allocation and preparation of quarterly reports.

    Role Requirements  

    • Bachelor's/Master’s Degree in health, science or equivalent;
    • Previous experience in the role;
    • Proven experience in Oncology and CNS;
    • Strong oral and written English language skills;
    • CRA certification as per DM 15/11/2011 is a plus;

    Personal Skills

    • Ability to think strategically in order to coordinate a team;
    • Strong communication and interpersonal skills;
    • Excellent organization skills and the ability to multitask;
    • Strong motivation to high performance and ability to cope with stressful situations;

    If you want to apply, please use the generic online application form.

  • Clinical Research Associated

    We are looking for a Clinical Research Associate with a minimum of two years proven experience in interventional studies to join our team.

    Role Overview 

    • Managing all aspects of clinical study from start up activities to site monitoring. These will include the conduction of the pre-study and initiation visits, routine monitoring, close-out of clinical sites and maintenance of the study files;
    • Monitoring of the assigned study sites according to protocol regulations, SOPs, GCP and ICH Guidelines;
    • Providing timely and accurate visit reports;
    • Ensuring all staff involved in the study will receive accurate instructions and tools to ensure patients safety;

    Role Requirements  

    • Bachelor/Master’s Degree in science or equivalent;
    • A minimum of 2 years experience of monitoring in interventional studies;
    • Certification as per DM 15/11/2011;
    • Proven experience in Oncology, CNS and rheumatology therapeutic areas is preferred;
    • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements;
    • Fluency in English is required;

    Personal Skills

    • Strong communication and leadership skills, ability to build both internal and external relationships and liaise with all professional figures involved in the study;
    • Ability to work with minimal supervision;
    • Good planning, organization and problem solving skills;
    • Ability to meet deadlines;

    If you want to apply, please use the generic online application form.

  • Start Up Specialist

    We are looking for a Start Up Specialist to join our team.

    Role Overview 

    • Managing work and team within a specific or broad area of site start up such as activation, regulatory, submissions, site contracts or regulatory records;
    • Advanced understanding of study objectives, study procedures and project related timelines;
    • Implementation, optimized site activation timelines, risk management regarding communication, coordination and quality;
    • Perform feasibility, site identification, site contract negotiation and other study start up activities;
    • Site document maintenance: prepare, review and submit submissions to the relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical study condict;

    Role Requirements  

    • Bachelor's/Master’s Degree in health, science or equivalent;
    • Excellent knowledge of the clinical trial process;
    • Advanced computer skills;
    • Previous proven experience with the OcSC AIFA platform tool;
    • Ability to develop accurate study related documents and coordinate a team;
    • Thorough knowledge of GCP and relevant country regulations/guidelines;
    • Robust relevant Research experience;
    • Strong English level required both written and spoken;
    • CRA certification as per DM 15/11/2011 is a plus;

    Personal Skills

    • Ability to think strategically in order to coordinate a team;
    • Strong communication and interpersonal skills;
    • Assertiveness, high flexibility and a detail oriented personality;
    • Excellent time management and organisation skills, ability to prioritize and multitask;

    If you want to apply, please use the generic online application form.

 

 

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