Clinical Data Manager (Lab Specialist) - Romania (Remote) - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel is currently seeking a Clinical Data Manager (Lab Specialist) to join us in either Romania or Poland, dedicated to a single sponsor.

This role will be responsible for performing Data Management activities focused on the management of local and central lab data and associated reference ranges, that support the sponsor’s commercial and development projects worldwide. The successful candidate will participate as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase I – IV studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance.

Working as a Clinical Data Manager (Lab Specialist) at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Responsibilities

• Support several clinical studies with minimal guidance.

• Review protocols for appropriate lab data capture including electronic Case Report Form (eCRF) design.

• Support the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members.

• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating CRF completion guidelines.

• Support the data edit check specifications/listings development and run data listings as required.

• Support the development of the Data Management documents for a clinical study.

• Manage and monitor local lab results, units and ranges with appropriate edit checks to ensure accuracy of lab results.

• May perform data entry of lab data into the EDC system and coordinate with relevant team members to obtain source data.

• Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries.

• Perform reconciliation of header data from external data sources against the clinical database.

• Support database upgrades/migrations including performing User Acceptance Testing.

• Maintain the study eTMF.

• Support database freeze and lock activities.

• Contribute to department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents.

• Perform broader Data Management activities, as required.

Here are a few requirements specific to this advertised role.

• BA/BS, preferably in the scientific/healthcare field.

• At least three years’ experience in Data Management for the pharmaceutical/biotechnology industry.

• Understands the scope and focus of Phase I – IV clinical studies and has a proven ability to perform some of the core Data Management tasks and interact with vendors.

• Extensive knowledge of lab data including results, units and conversions.

• An understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.

• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

• Strong English language written and verbal communication skills.

• Able to travel to off-site meetings or training seminars on occasion.

• Experience/ability to work with a globally distributed team.

• Good communication/interaction skills and ability to work in a dynamic and growing organisation.

• Solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with Medidata Rave Local Lab Module and the use of Rave Batch Uploader to manage local lab data entry is desirable.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

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