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Clinical Study Manager Job

Eingestellt von Yoh

Gesuchte Skills: Client

Projektbeschreibung

CLINICAL STUDY MANAGER needed for a CONTRACT opportunity with Yoh's client located in Wilmington, DE.

What You'll Be Doing:
- Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA.
- Lead Local Study Team(s) consisting of monitors and study administrator(s).
- Lead and optimize the performance of the local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
- Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team.
- Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters.
- Proactively identify and facilitate resolution of complex study problems and issues.
- Organize regular Local Study Team meetings on an agenda driven basis.
- Actively work towards achieving good personal relationships with all local Study Team members.
- Report study progress/update to the SMO Study Leader/Team.
- Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary.
- Communicate and co-ordinate regularly with National Co-ordinating Investigator/National Lead Investigator on recruitment and other study matters.
- Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals/sites.
- Plan and lead national Investigator meetings as needed, in line with local codes
- Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
- Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan.
- Ensure timely preparation of country SMA, fSMA and Master CSA.
- Ensure completeness of the Study Master File and ensure essential documents are sent to SMO/Hub location/site.
- Ensure local Serious Adverse Event (SAE) reconciliation takes place.
- Facilitate translation of documents (ICFs, patient diaries, participation cards, etc.) through external providers.
- Ensure timely submission of proper application/documents to EC/IRB.
- Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.
- Set up and maintain the study in IMPACT at study country level.
- Ensure accurate payments related to the study are performed.
- Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and Procedural Documents.
- Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File.
- Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and CA&A.
- Provide input to process development and improvement.
- Provide regular information to Line Managers (SMM Director/CRM) at country level on study/ies and planned study milestones/key issues.
- Update Line Managers (SMM Director/CRM) about the performance of the monitors/CRAs.
- Ensure that study activities at country level comply with local policies & code of conduct.

What You Need to Bring to the Table:
- BA/BS preferred
- Five (5) plus years of experience in Clinical Research
- Must have experience managing outsourced trials

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

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Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    Wilmington, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung

  • Skills:

    client

Yoh