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Assc Director Clinical Operations - Rare or RNAi

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Design

Projektbeschreibung

Clinical Operations - Rare / RNAi

A position has become avalible that I believe suits your profile, the compoany are a mid size innovative Pharma approaching an exciting stage in the companies clinical trials and overall growth.

Clinical Operations leadership & hands on Clinical Poerations abilitys is needed to redefine and focus a flagship program across several studies that need to be supported through out this year.

I am in search of a Clinical Operations Director for an organisation based in Cambridge Mass.

I am in search of a Clinical Operations Manager with ideally experience within Genetics, Rare / Orphan diseases, RNA interference, RNAi, RNAi technology or Chronic disease
* Someone with a strong clinical operations background ( as attached in your job description document).
* A person with very successful experience in CRO-models.
* Early phase experience I-III
* A candidate that has had progression in their career.
* Orphan/ Rare disease, Chronic disease knowledge
* Somebody that is willing to be hands-on but is able to provide strategic direction and oversight of the clinical research activities.
* Program Management and Budget management.
* Educational level or background in Science, Biology, Chemistry or Clinical Therapy.

The work is done in several locations across the world: Portugal, Spain, UK, Argentina, Sweden, France, etc.

Job description:

Manages large, complex projects with great attention to detail and interfaces with project teams effectively. Integrates and applies knowledge and experience to meet timelines and drive clinical development process, demonstrating initiative in all aspects of work. Reviews site regulatory documents for content and appropriateness. Assists in authoring appropriate sections of Investigator Brochures, an IND and annual report. Independently works with medical writer to draft clinical study reports, protocol sections and ICFs. Develops methods for training staff and investigators. Manages vendor selection process and ongoing management of CRO / vendor; may require minimal supervision of complex issues. Manages clinical trial product supply projections, and labelling of study drug per country requirements.

Coordinate with internal laboratories on pk component of study (eg, kit design, develop laboratory manuals, sample management, data transfer, review of results). Proposes and implements innovative ideas. Manages technical and scientific areas of a project, and oversees project budget and deliverables with minimal supervision.

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Massachusetts, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Medien/Design

  • Skills:

    design

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland