clinical operations manager

yayınlanma
şimdi başvur

iş ilanı detay

yayınlanma
lokasyon
istanbul, ıstanbul (anadolu)
sektör
Pazarlama
referans numarası
6795

iş tanımı

We are looking for a 'Clinical Operations Manager' for our client operating in pharmaceuticals industry.

Oversee performance of CROs, third party vendors, and field CRAs including co‐monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Director or CRO as appropriate.

Perform clinical data review of data listings and summary tables, including query generation.

Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits.

Develop and maintain good working relationships with investigators and study staff.

Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures.

Track and report on progress of study including site activation, patient enrollment, monitoring visits.

Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team. (autonomy may vary with experience)

Investigate queries, monitor discrepancies.

Manage investigational product (IP) accountability and reconciliation process.

Responsible for review or approval of IP release packages.

Negotiate and manage the budget and payments for investigative sites, if applicable.

Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents.

Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work.

Assist with CRA and third party vendor training on protocols and practices.

Assist in identification and hiring of appropriate CROs and third party study vendors.

Other duties as assigned.

nitelikler

Experience in managing industry sponsored clinical (pharmaceutical) trials.

Cross‐functional team leadership experience preferred. (at least 2 years)

Management of international clinical studies preferred.

Orphan, immunology and/or oncology study experience preferred.

Experience managing vendors, including performance assessments and total financial management. (invoice review, change order management, budget reforecasting, etc.)

Proficient with MS Word, Excel and PowerPoint. Experience with MS Access and MS Project a plus.

Strong interpersonal, communication (written and verbal), and organizational skills.

Demonstrated ability to work independently as well as part of a multi‐functional study team.

Able to motivate a team to work effectively under a changing environment.

Able to solve problems under pressure.

Self‐motivated and able to work effectively in a matrix/team environment.

Availability for potential travel domestically and internationally.

6‐8 years Clinical operations work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process.

Global Phase III experience in Orphan, immunology and/or oncology drug development desirable.
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