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Principal Study Management Associate (Contract)

Eingestellt von Apex International

Gesuchte Skills: Marketing, Client

Projektbeschreibung

Job Title: Principal Study Management Associate

Location: Buckinhamshire

Duration: ASAP 12 Months

The Client: Global pharma company

Benefits: Competitive daily rate of pay available - Full details available on application

The Role:

Ensure all site related activities and files are completed per the SOPs. Be key point of contact for study specific questions from both internal (eg, site monitors, clinical services specialist) and external (eg, site personnel, vendors) customers. They facilitate communication across departments and elevate site and study issues as appropriate.
Review clinical data through monitoring reports and data listings in order to monitor overall clinical data quality and identify and resolve potential study or site issues as appropriate. They perform quality checks of all study plans (eg, monitoring plan) and study reports. They review and code protocol deviations.
Set-up, test, review, and update clinical systems (eg, CTMS) and tracking tools. Responsible for collecting and tracking study specific data and producing clinical status, trend, and metric reports to assist the manager in proactive study management and contingency planning.
Responsible for the logistical tasks associated with the preparation, collection, review and tracking of the master and site non-regulatory file documents. Ensure the accuracy and completeness of all study files prior to final archival.

Full details available on application

The Candidate:

Minimum Requirement

B.A./B.S. preferably in science or health-related field
Previous experience of clinical study management
Oversight or mentoring of more junior study monitors (direct or indirect) preferred

Knowledge and Skills

Must have a good understanding of the following:
Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
Knowledge of concepts of clinical research and drug development, and
General therapeutic area education and training

In addition to the essential skills, the incumbent must have the ability to:

Handle and prioritize multiple tasks simultaneously,
Work effectively in a team/matrix environment,
Understand technical, scientific and medical information,
Handle conflict management and resolution,
Understand clinical study budgets,
Plan, organise, project manage and analyse data, and
Demonstrate full competency in Microsoft Office programs.

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.

About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email

Apex International hold Investors in People status and are a corporate member of the Recruitment and Employment Confederation (REC).

Recommend a Friend Reward!!!! If you refer someone who is not currently registered with us and we find them a new position, Apex will repay you with a £200 voucher bonus (of your choice!)

Our Passion - Your Profession - A consultative approach to recruitment.

We match professional candidates to the best permanent, contract and interim roles in the market

Website:

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Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Apex International