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Job Details

Local Trial Manager BCP - LD

Company: Docs Global (Continental Europe)
Location: Belgium,Belgium
Reference: Ref AS-021938
Closing Date: 17 Aug 17
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

LTM is a person within Trial Co-ordination and Site Management responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries. The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard...

Requirements:

Roles & Responsibilities of the position

1. Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and GTM. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
2. Collaborates with the CPL, GTM, local management/Country Head and Protocol Owner to select final site list.
3. Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial.
4. Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
5. Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
6. Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints). Uses study tools and management reports available to analyze trial progress
7. Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.
8. May submit requests for vendor services and may support vendor selection.
9. May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget.

Job Requirements

A minimum of a BA/BS degree is required.
A degree in a health or science related field is preferred.
Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred.
Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
Solid communication and computer skills required. Proficient in speaking and writing the country language and English language.
Good written and oral communication skills.

Remuneration & other details

Competitive salary and benefits.

Interested? Do not hesitate to contact Carine Louckx at carine.louckx@docsglobal.com or by phone +32 (0)16 394 733

Apply for this job: Local Trial Manager  BCP - LD

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Marlow
Buckinghamshire
SL7 1HZ
England
Website:  Visit Our Web Site

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