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Catherine SKA

NIVELLES

En résumé

Venez aussi me voir sur Linkedin: be.linkedin.com/in/clinska/
Mon GSM: 0032 479 97 04 14, à votre écoute!

- PHARMA RESEARH EXPERIENCE:
13 years expertise with Sponsors, CROs, Investigators, Ethics Committees and all range of trial staff.
Ability to work in a self-directed manner, solution oriented, quick starter, business minded and able to provide overall team support.

- Areas of Expertise:

Experience in audit & compliance visits locally & internationally, CAPA management, SOP & study documents writing/review, Investigators GCP training, etc.

Experience in providing Clinical Research related trainings (basic to advanced courses in clinical development, CRA, PM, site staff, regulatory, GCP, etc).

Demonstrated experience in international trial management (operational, start-up, conduct, budgeting, resources review, reporting, vendors), local & international project planning & coordination, local start-up activities, submission to EC/HA, site financial contract negotiation, CRA activities including site selection/ initiation/ monitoring /close-out, preparation & review of materials related to clinical trials (monitoring guidelines, recruitment strategy, SDV plan, Com plan, SOP, etc), SUSAR reporting.

Management & coaching of local & international study team members (all levels, Pharma and CROs/vendors).

- THERAPEUTIC AREAS:
Oncology, diabetes, orphan disease, neurology, hematology, gynecology, rheumatology, vaccines.
Field: Drugs & devices.

- CORE ACTIVITIES:
Quality & GCP compliance management
Clinical Trainings
Clinical Project Management: international/local phases I-III

- BACKGROUND:
International Project Manager phases 2-3 trials. Clinical Trainer. CRA & local PM in Belgium for international phases 2-3 trials, pharmacovigilance. Physiotherapist degree.

- CURRENTLY:
Freelance Clinical Research Professional at Clin-SKA sprl. Contacts: 0032 (0) 479 97 04 14 or catherine.ska@clin-ska.net

- SPECIALITIES:
- International Clinical Project Management phases1-3
- Clinical QA/compliance/CAPA management
- Clinical training
- Clinical team management

Mes compétences :
Essais cliniques
Coaching d'équipe
Formation
Recherche médicale clinique
Compliance

Entreprises

  • European Clinical Center for Research Training - Consultant trainer

    2013 - maintenant Consultant for the European Center for Clinical Research Training (ECCRT): Consultant Trainer for public courses and internal SynteractHCR courses for all levels (junior, senior) for CRA, PM and site staff. Available for sponsor’s tailored courses and support for sites excellence. Business development for trainings

  • Viropharma - European clinical consultant

    Faenza (RA) 2012 - maintenant Consultant for Viropharma EU sprl: Trial Project Management Research Area: Hereditary Angioedema (HAE) outsourced studies (international phases II & III trials), orphan diseases.
    Achievement: Unblinded project management, EU CRO team development.

  • Roche - Country study manager

    Boulogne-Billancourt 2008 - maintenant Clin-SKA Consultant for Roche Belgium. Trial Project Management. Research Area: oncology, diabetes, neurology, haematology, RA, outsourced studies (international phases II & III trials). Achievement: Start-up & conduct of program of 4 studies (phases 3) with high success, effective recruitment in challenging oncology trial.

  • GlaxoSmithKline - Central study coordinator

    Marly-le-Roi 2007 - 2007 Consultant in research area: H5N1 pandemic vaccines (international phases II & III trials).

  • Novo Nordisk - Local trial manager/CRA

    La Défense Cedex 2003 - 2007 Research areas: neurology, diabetology, endocrinology, gynaecology (international phases II & III trials)

  • Quintiles - Clinical Research Associate

    Durham 2001 - 2003 Research areas: neurology, dialysis, rheumatology and vaccines (international phases II & III trials).

  • Covance - Drug safety assistance

    Princeton 2000 - 2001 Review of SAE reports, medical writing, EC/HA reporting, implementation of SAE plan, reconciliation plan, randomisation and unblinding plan.

  • Clin-SKA sprl - Clinical quality compliance, CAPA management, project management & trainings in pharma research

    2000 - maintenant

Formations

  • Institut D'Enseignement Supérieur Parnasse Deux Alice (Bruxelles)

    Bruxelles 1996 - 1999 Gradué

  • Highschool California US (San Francisco)

    San Francisco 1994 - 1995 Secondaire supérieur

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