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Job Details

Clinical Data Manager

Company: CROMSOURCE
Location: Germany
Reference: HQ00001265
Closing Date: 20 Jun 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Description   Job Title: Clinical Data Manager (m/w) Location: Munich, Germany   TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Data Manager (m/w) to strengthen the team of one of our TOP Pharmaceutical client Companies in Munich, Germany.   Main Job Tasks and Responsibilities   · Provide clinical data management support to the clinical trial teams...

Requirements:

Description

Job Title: Clinical Data Manager (m/w)

Location: Munich, Germany

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Data Manager (m/w) to strengthen the team of one of our TOP Pharmaceutical client Companies in Munich, Germany.

Main Job Tasks and Responsibilities

· Provide clinical data management support to the clinical trial teams (CTT)

· Participate in the review of the clinical trial documents (e.g.protocols, case report forms and statistical analysis)

· Oversee the development and implementation (including change management) of clinical data management activities outsourced to the vendor in a clinical trial (i.e. Data Management Plan, eCRF, Database Specification, Data Transfer Plan, UAT Test Scripts and Execution Logs, etc.) to ensure quality and adherence to timelines

· Participate in meetings with vendors to review project plans and timelines, address and resolve issues identified in the trial and requests from the CTT

· Coordinate the UAT of eCRF build and validation documents including but not limited to edit check document, issue logs, UAT summary report with the vendor

· Participate in the definition and implementation of eCRF standards

· Ensure reconciling of SAE data in Safety Database and Clinical Database by the vendor

· Support in defining and quality control of data listings, summary table validation, data specifications and/or process data transfers by the vendor in preparation for statistical review

· Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock - included but not limited to data reconciliation and /or coding in agreement with all regulatory requirements

· Coordinate the archiving of study databases and related documents

· Author of the Data Management related SOPs and responsible for the period update of these SOPs

Education and Experience

· Successfully completed professional training (Master´s degree or equivalent) in the field of data management

· At least 5 years of data management and/or related work experience in pharmaceutical industry

· Experience with EDC systems like ORACLE. InForm or Medidata Rave

· Experiences with other data management relevant systems, such as IVR systems and CDMS

· Experience in (e)CRF design and programming

· Knowledge of CDISC / CDASH / SDTM standards

· SAS and "R" programming experience

· Ability to coordinate data management activities with external vendors

· Good understanding of global clinical trial practices, procedures and methodologies (such as ICH-GCP and 21 CFR part 11)

· Experience in the conduct of Phase I-IV trials (preferably with health authorities inspection experience)

· Experience in database decommissioning and archiving process

· Excellent organizational and time management skills

· Team player with well-developed interpersonal abilities

· Good written and oral communication skills in English and preferably German

If you have the experience needed for this position, please contact Alexander Sourounis, Senior Consultant TalentSource Life Sciences Unit, and send your CV in WORD format to alexander.sourounis@cromsource.com

Why TalentSource Life Sciences/Cromsource

CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Data Manager

Apply for this job: Clinical Data Manager

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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