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Clinical Research Manager - sponsor dedicated - Hungary - Budapest

Covance 1/11/2019 8:12:01 AM
JOB ID: 21408 Category: Clinical Operations Entry Level
Budapest, Hungary

   

 

Job Overview

Clinical Research Manager - sponsor dedicated - Poland - Warsaw

We are currently looking for talented Clinical Research Manager to join our team in Moscow. You would be working within our Flexible Solutions department dedicated to one sponsor/client.

Would you like to work for one of the best known big pharma companies? Our sponsor is a global mid sized pharma company with high working standards. Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials. Do you like responsibilities and challenges? In this position you will be accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Our sponsor invests heavily in training and crafts modern system of Clinical Trials so if you are passionate about working with excellent people and expand your horizons feel free to reach us.

Responsibilities:

* Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team
* Responsible for project management of the assigned studies: actively plans, drive and track execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out
* Review Monitoring Visits Reports and raise performance issues and training needs to CRA manager and/or functional vendor and internal management as needed
* Perform Quality control visits as required
* Lead local study teams to high performance: train in the protocol other local roles, closely collaborate with and supports CRAs as protocol guide and coordinate activities across the different local country roles ensuring a strong collaboration
* Responsible for crafting and executing a local risk management plan for assigned studies
* Ensure compliance with CTMS, eTMF and other key systems
* Raises as needed different challenges and issues
* Responsible for collaboration with functional outsourcing vendors, investigators, other external partners
* Country point of contact for programmatically outsourced trials
* Serve local business needs as applicable in his/her country (If delegated can sign contracts and run budgets)
* Collaborate internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies
* As a customer-facing role, this position will build business relationships and represent the company with investigators
* Share protocol-specific information and standard methodologies across countries\clusters

Education / Qualifications

University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution

Experience

Previous Experience in clinical research in pharmaceutical or CRO industries

Deep understanding of local regulatory environment

Strong understanding of clinical trial planning, management and metrics is important as well as the ability to focus on multiple deliverables and protocols at a time

Ability and skills to lead resource allocation, processes (and controls), productivity, quality and project delivery

Strong organizational skills and time management skills

Excellent interpersonal skills

Proficiency in written and spoken English and local language


Position Type: Full-Time

Location: Budapest, HUN - Hungary



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If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

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If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).