Clinical Data Manager



COVANCEis a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.



We are recruiting for our Data Transfer team and are currently seeking to hire a Data Manager to help support the team in Mechelen, Belgium or Indianapolis, USA.



About the Job

Within this position, your duties will include:

• Engage client data management during start up:

Create protocol folder(s) for study documentation

Add entries into individual protocol spreadsheet

Review Statement of Work (SOW) for study scope

Ensure start-up packet delivery to clients

Contact clients for initial study discussion and determine authors of Data Transfer Specifications (DTS)

Provide recommendations and alternatives to optimize data quality

Collaborate with clients to finalize Data Transfer Specifications (DTS)

Obtain final client approval on Data Transfer Specifications (DTS)

• Act as a data liaison between Clinical Data Management and all other Covance departments and business units:

Consult with Medical Affairs via a Med/Tech Affairs Request Form

Collaborate with Project Management proactively and reactively regarding study questions

Manage and resolve issues with Specimen Management

Initiate data changes with the appropriate department and revise all non-compliant requests

Partner with other Covance departments and business units, and provide integrated support and process improvements as needed

• Create standard data transfer format(s) in compliance with client requests while adhering to both internal processes and regulatory standards:

Build and modify Data Transfer formats as needed

Create test data if needed

Quality Check (QC) test files

Deliver test files to clients and log into the metrics tool

Obtain client approval and store auditable documentation

• Provide ongoing client support (study maintenance):

Create global transmission instructions

Schedule appropriate frequency of data transfers

Address errors and client issues including queries

Participate in study-related meetings

Collaborate with clients regarding study modifications

Confirm changes and send files as needed

Maintain auditable documents

Facilitate Data Management functions of end-to-end data lock processes

Represent Clinical Data Management in client visits, audits, inspections and bid defenses as needed

Collaborate with clients regarding new service requests

Support billing of services as needed

• Attend training to increase Data Manager's capabilities (including corporate, departmental and sponsor-related training).
• Ensure uninterrupted client service:

Support peers by sharing technical knowledge and customer service skills

Back up peers as needed

• Record data transfer activities and maintain protocol portfolios as required to track workload and productivity.

About You

To be successful in this position, you will need to be educated to a Degree level (or equivalent) in a relevant area or 4 years Covance experience.

Additionally, you will need to demonstrate:

• Strong organizational, planning and critical-thinking skills.

• Well-polished, inclusive, and engaging communication skills (written and verbal).
• Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment.
• Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
• Ability to use standard Microsoft suite of software products.
• Conversant with databases and database terminology.
• Strong technical aptitude.
• Customer Service experience.
• Data Management and/or Clinical Trials experience

Get to know Covance

Covance, the drug development business of LabCorp, is the world's most comprehensive drug development services company. Because of our broad experience, from early research to commercialization, our more than 20,000 employees from across the globe are in a unique position to supply insights that go above and beyond testing. Our team's impact on healthcare is remarkable. Through their everyday work they've supported 100% of the top 50 drugs on the market and all the oncology drugs approved in 2016. Even though we span multiple businesses, we operate as one, sharing our knowledge to improve our efficiency and deliver on the promise of a healthier world.

The Covance team is driven by an energized purpose to improve health and improve lives across the globe. Here, you'll work alongside exceptional people who each play an important role in bringing new scientific discoveries and therapeutic area advancements to life. And, because we span the drug development spectrum, you'll directly impact a wide-range of initiatives as you explore unique career paths and discover your extraordinary potential.

Get ready to make a difference as we speed the delivery of groundbreaking therapies and improve lives of countless individuals.

EEO Statement

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.

Please apply with a CV in English


Education/Qualifications:
BS/BA four-year degree or equivalent education, or 4 years Covance experience
Experience:

• Strong organizational, planning and critical-thinking skills.
• Well-polished, inclusive, and engaging communication skills (written and verbal).
• Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment.
• Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
• Ability to use standard Microsoft suite of software products.
• Conversant with databases and database terminology.
• Strong technical aptitude.
• Customer Service experience.

Data Management and/or Clinical Trials experience
Locations:
Mechelen, Belgium;
Indianapolis, Indiana, United States