Kelly Services REMOTE Clinical Data Management Quality Lead (CCDM) in Gaithersburg, Maryland
Kelly IT Services is currently recruiting for a REMOTE Clinical Data Management Quality Lead to become a part of an organization with a goal to get things done in a pragmatic, deliberate manner. This will be a long term, multiyear contract opening with a well known Pharmaceutical company located in Gaithersburg, MD.
Qualified and interested candidates APPLY NOW!!
You can email your resume directly to Amy Kowalski - firstname.lastname@example.org
Data Management Quality Leader - REMOTE
Resources can be remote, EST time zone preferred
Remote candidates should be available to be on-site in Gaithersburg during the first week for training and ramp up
Minimum of 5 years experience in related field
Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management in Oncology
To provide DM subject matter expertise to the study team(s) and is responsible for overseeing and managing all DM activities for the study.
Serves as a core team member of the study team(s) and is accountable for all DM-related communications, specifications, and documentation that includes but not limited to the Data Management Plan (DMP).
The DMQL is responsible for the overall quality and integrity of the database with respect to “Critical to Quality” (CTQ) data points predefined by Clinical and Biostats prior to the start of a study.
The DMQL will “project manager” the Data Quality Plan to ensure CTQ data points are of the highest integrity and completeness.
Number of studies assigned to DMQL will be based on a given therapeutic area, depending on size, complexity and working model.
Serves as the expert in Clinical Research Data Management to provide oversight and advice to the clinical project team(s) regarding the DM activities and deliverables
Manages and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization
Provides input to the DM related activities associated with regulatory inspections/audits
Provide DM business expertise and consultancy in the selection and use of software systems and vendors
Development and oversight of DM processes and standards and functional leadership:
Oversee quality and consistency with strategies and standards across therapeutic areas
Works with the Standards Group to provide input into clinical project standards and processes based on industry best practices
Facilitates and manages valid change requests of project standards to the Standards Committee
Assesses CRDM needs and areas of improvement and recommends changes to the operating model
May be asked to provide strategic DM expertise to Global Clinical Initiatives
Management and oversight of vendor performance.
Reviews, assesses and manages DM delivery against KPIs and overall DM performance
Provides input into the contract process for the CRDM vendor
Manages all DM timelines and DM Deliverables for assigned studies
Ensures DM billing is accurate and forwards recommendation to CDM for payment of invoices.
Accountable for the execution and overall quality of DM activities and deliverables.
Acts as the single point of contact for all data management deliverables for the study team during the study set-up phase, responsible for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities.
Provide guidance and supervision to Lead Data Managers/DM Team Leads working on the study (CRO or in-house)
Accountable for “real time” Data Management, ensuring that DM conducts initial reviews within 5 calendar days of a patient’s data entering the EDC system, and manages the average query aging to no more than 30 calendar days.
Accountable for the overall quality and completeness of the Data Management Plan (DMP).
Responsible for working closely with the Centralized Data Monitoring (CDM) group to ensure quality and integrity of our most important data points.
Education: Minimum of a BS in life sciences or computer science degree
Strong Data Management experience in the Biotech/Pharma/CRO industry (at least 5 years)
Strong Oncology Therapeutic Expertise (at least 3 years)
Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities
Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
Demonstrate understanding and experience in query management process and reconciliation activities
Strong communication and interpersonal skills
Ability to work independently under direction and close supervision
Excellent written and verbal communication skills
Effective problem and conflict solving skills
Ability to work in a global team environment
High attention to detail and accuracy
Demonstrated knowledge of clinical and pharmaceutical drug development process
State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
Demonstrated understanding of clinical data system design / development / validation and system interoperability.
Excellent understanding and demonstration of values and behaviors
Excellent organizational and analytical skills
Demonstrated ability to work effectively with external partners
Ability to interact effectively with all levels of management
This position is recruited for by a remote Kelly office, not your local Kelly branch. If you have questions about the position, you may contact the recruiter recruiting for this position (email@example.com). Due to the high volume of responses anticipated, only select candidates will be contacted. Thank you!
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm