Covance Clin Data Mgr I in Lisbon, Portugal

Job Overview

We are currently looking to recruit experienced Project Data Managers for our Biometrics group. Candidates with significant prior experience and a proven track record in delivering on projects will be considered for the Project Data Manager role.

We are looking for like-minded people that want a job designed for career success. Experience in any of the following Data Systems would be beneficial.

• Medidata Rave®

• MedNet, iMedNet™

• Merge eClinicalOS®

• Oracle® InForm

• Perceptive DataLabs®

We can offer competitive salaries, benefits that are designed around you and a strong support mechanism and dedicated coaching to develop your career within Data Management.

This is a full time permanent opportunity.

Primary duties:

• Support clients’ business objectives by ensuring the accurate and timely acquisition of diverse clinical data through efficient CRF/eCRF design, edit specifications, and query resolution processes

• Serves as a Data Management Lead for one or more complex studies

• Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and other internal teams.

• Develop and implement project plans for relevant Data Management projects.

• Create project specific Data Management Plans (DMPs)

• Provide input, assistance and/or oversight with preparation of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification

• Delegate tasks to CDA I and CDA II staff members

• Provide technical and business process input/expertise

• Assist with and/or oversee the creation of test data for entry screens and edit checks

• Serve as primary contact for DM with all relevant parties including but not limited to Clinical Operations and Sponsor, informing stakeholders if there is a need to deviate from project scope or plan

• Participate/attend Sponsor requested meetings as required

• Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections

Requirements:

• Life Sciences degree or Nursing qualification

• Ability to maintain confidentiality of data and information during interactions with staff at all levels

• Prior experience in Data Management in the pharmaceutical, biotechnology, medical device/diagnostics or clinical trial industries.

• Effective communication skills

• Working experience with Medidata Rave, Inform and Oracle Clinical is preferred

• Strong leadership qualities and experience of supervising other Data Managers

• Hands on experience with EDC systems

• Good knowledge of the drug development life cycle

• Understanding of the principles of ICH GCP and regulatory requirements

• Good computer literacy with working knowledge of Windows and Microsoft Office applications

• Good oral and written communication, organisational skills and personal presentation

• The ability to communicate effectively in English

• Experience working within a team environment under time and resource pressures

• Proven experience in clinical trials with knowledge of SOPs, regulatory reporting requirements and accepted practices

• Confident dealing with external and internal clients and providers

Education / Qualifications

• Life Sciences degree or Nursing qualification

• Ability to maintain confidentiality of data and information during interactions with staff at all levels

• Prior experience in Data Management in the pharmaceutical, biotechnology, medical device/diagnostics or clinical trial industries.

• Effective communication skills

• Working experience with Medidata Rave, Inform and Oracle Clinical is preferred

• Strong leadership qualities and experience of supervising other Data Managers

• Hands on experience with EDC systems

• Good knowledge of the drug development life cycle

• Understanding of the principles of ICH GCP and regulatory requirements

• Good computer literacy with working knowledge of Windows and Microsoft Office applications

• Good oral and written communication, organisational skills and personal presentation

• The ability to communicate effectively in English

• Experience working within a team environment under time and resource pressures

• Proven experience in clinical trials with knowledge of SOPs, regulatory reporting requirements and accepted practices

• Confident dealing with external and internal clients and providers

Experience

Life Sciences degree or Nursing qualification

• Ability to maintain confidentiality of data and information during interactions with staff at all levels

• Prior experience in Data Management in the pharmaceutical, biotechnology, medical device/diagnostics or clinical trial industries.

• Effective communication skills

• Working experience with Medidata Rave, Inform and Oracle Clinical is preferred

• Strong leadership qualities and experience of supervising other Data Managers

• Hands on experience with EDC systems

• Good knowledge of the drug development life cycle

• Understanding of the principles of ICH GCP and regulatory requirements

• Good computer literacy with working knowledge of Windows and Microsoft Office applications

• Good oral and written communication, organisational skills and personal presentation

• The ability to communicate effectively in English

• Experience working within a team environment under time and resource pressures

• Proven experience in clinical trials with knowledge of SOPs, regulatory reporting requirements and accepted practices

• Confident dealing with external and internal clients and providers

Job Number 2018-24323

Job Category Clinical Data Management

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.