OmniTek Consulting is an established and growing firm founded upon the guiding principles of Respect, Integrity, Humility, Positivity, and Accountability.
As our firm continues to grow, we are seeking a Clinical Data Manager to support a life sciences client based in the DC area.
Provide clinical data management (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
Responsible for development and oversight of DM processes and standards and functional leadership:
Oversee quality and consistency with clients 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 client 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. Required
Minimum of a BS in life sciences or computer science degree
Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management in Oncology
Minimum of 5 years' experience in related field
Strong Data Management experience in the Biotech/Pharma/CRO industry (at least 5 years)
Strong Oncology Therapeutic Expertise (at least 3 years)
Must be a self-starter and action oriented
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 desired
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 organizational and analytical skills
Demonstrated ability to work effectively with external partners
Ability to interact effectively with all levels of management
OmniTek Consulting believes in recognizing and supporting our employees as they build successful careers balanced with healthy lifestyles. We believe in feedback, coaching/mentoring, and creating an environment where each team member is encouraged to contribute, innovate, and inspire. We are pleased to offer a well-rounded benefits package that includes:
Comprehensive Health, Life, and Disability Insurance
Vacation and Holidays
Full-service Wellness Program
Discounted Gym Membership
OmniTek Consulting is an EEO employer as defined by the EEOC.