Clinical Data Project Manager - Homebased

covance

Netherlands

4 dagen geleden

Job Overview :

Joining Covance Flexible Solutions (FSPx) will offer a rewarding career, a chance to work in an energetic & team-oriented workplace, and access to competitive benefits.

With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

Our unique opportunity will allow you to bring your specialized discipline to a core team outsourced to a world class leading global healthcare company.

Dedicated to our Client 100% of the time, you will play a key role in the drug development cycle and see a product through to launch with the support of both a dedicated Covance line manager and our client project teams.

Your role :

The Data Project Manager role is a great opportunity to work within our sponsor dedicated department and have this unique relationship with a sponsor. Homebased in Europe.

Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing.

Effectively plan and execute multiple Data Management projects simultaneously

Assign tasks and responsibilities within Data Management to team members, in a manner that : optimizes team capability;

delivers timely and accurate results; and supports the needs of the business

Ensure that assigned team executes Data Management functions in accordance with Chiltern and / or sponsor Standard Operating Procedures (SOPs)

Serve as Data Management Lead on selected projects

Create study 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

Oversee and contribute to 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

Manage sponsor relationships and triage issues as appropriate

Ensure that project team member performance supports project budget and delivery requirements

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

Participate / attend Sponsor requested meetings as required

Perform other duties as required by the Department

Education / Qualifications :

University degree in Medical / Life Science / Computer Science

Experience :

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

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