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Study Start-up Project Manager - UK or Ireland

Covance 1/11/2019 8:10:51 AM
JOB ID: 22084 Category: Clinical Operations Entry Level
Regional, Ireland

   

 

Job Overview

Covance is looking for a Study Start-up Project Manager to work 100% dedicated to one of our clients, a leading pharmaceutical company. You will be responsible for Project Managing both the regulatory and financial start-up activities for studies within the UK and Ireland. This role could suit a Senior CRA looking for less travel or an Experience d Study Start-Up specialist looking to move into a more senior Project Management role

Check out the role responsibilities and requirements below:

The SSU Project Manager is accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

FINANCIAL:

Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value. Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out.

Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD.

COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS:

Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.

Development of local language materials including local language Informed Consents and translations.

Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

MANAGEMENT & QUALITY OVERSIGHT:

Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.

Responsible for quality and compliance in assigned protocols in the country. Contributes to the development of

local SOPs. May oversee contract workers (CTCs) and local vendors as applicable.

COLLABORATION: Works in close collaboration internally with GCTO country operations (CRM,CTC,CRA), CQM, Finance, Medical Affairs, Regulatory Affairs, PV, Business Compliance, Legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.

LOCAL PROCESS OVERSIGHT:

Oversight and coordination of local processes.

Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical, regulatory, safety and finance systems.

Problem solving and Process Improvement is essential to this position. Requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include:

1) Issues in budget / CTRA negotiations

2) Quality and compliance issues

3) Regulatory and legal issues

4) issues related to functional area deliverables that could jeopardize protocol milestones.

Education / Qualifications

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

In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research Experience in pharmaceutical or CRO industries or Experience in a health care setting will be considered

Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries

Thorough understanding of the drug development process

Fluent in local office language and in English, both written and verbal

Experience

Minimum of four-six (4-6) years of clinical research Experience within the Study Start-Up area looking after Submissions to the LA and EC, protocol amendments, contracts and contract negotiation.

Budget management.


Position Type: Full-Time

Location: Regional, IRL - Ireland



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

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.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

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).