Job Description What we do?
SPECTRAFORCE is an award winning global staffing, IT services
and consulting company that specializes in providing top talent and
solutions for clients throughout North America and India. We pride
ourselves on our partnership with our clients, MSP/VMS providers,
and our employees, who have enabled us to continually be ranked as
a Top Supplier in the 75+ different clients we support.
Senior Manager-Clinical Data Solutions
• Responsible for timely and high quality data management
deliverables supporting the client portfolio.
• Establish asset and study level strategies and services,
including excellence in the application of standards.
• Conduct oversight using, predictive data monitoring practices
from database activation through database release and
• Contributes to the management of vendor partnerships to
maximize effectiveness and maintain budgets.
• Provides and enables solutions for complex problem solving
that align with the client values.
• Serves as a clinical data management expert and provides
guidance on CDISC standards.
• Responsible for vendor oversight activities across global
development programs. Represents data management function on the
Clinical Sub-team ensuring aligned expectations between the CRO and
client for all data related deliverables, especially in support of
key decision points and regulatory submissions.
• Contributes influential leadership in collaboration with other
client Stakeholders to ensure established milestones and
deliverables are met with the highest degree of quality.
• Provides input to functional governance with client’s
strategic suppliers. Partners with appropriate stakeholders to
resolves issues escalated from the vendor and/or cross-functional
• Ensures achievement of major data management deliverables and
milestones in coordination with other functions including the
Therapeutic Area Units, Clinical Operations, Statistical
Programming and Statistics.
• Ensure archival and inspection readiness of all Data
Management Trial Master File (TMF) documents
• Oversees the planning and management of external Data
Management budgets and timelines to ensure accuracy, understand
trends in variances and support continuous improvement in
• Represents function in external professional initiatives and
organizations such as SCDM, CDISC, DIA, etc. to identify industry
best practice and increase the visibility of client.
• Participates and represents function in formal inspections and
audits as requested.
• Other duties as assigned
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• BS/BA required preferably in a health-related, life science
area and with a minimum of 10 years data management and/or drug
• Proven track record of strong project management skills and
experience managing data management activities for large drug
• Experience with all phases of development and at least 2
• Ability to handle multiple development programs
• NDA/CTD Experience.
• Strong knowledge of electronic data capture and data warehouse
technologies as applied to clinical trials.
• Strong working knowledge of (e)CRF design and data management
functions/activities as applied to standards library development
• Good understanding of CDISC standards, and experience
• Strong knowledge of clinical study reporting requirements
including SAS programming.
• Advanced knowledge of office software (Microsoft Office).
• Solid understanding of clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and processes.
• Advanced knowledge of FDA and ICH regulations and industry
standards and quality control principles.
• Experience in medical coding in the
pharmaceutical/biotechnology industry including knowledge of coding
• Good working knowledge of general statistical programming
processes and practices.
Advanced knowledge of medical terminology, medical coding,
laboratory reference ranges, clinical diagnostic procedures,
anatomy/physiology and nature of disease processes.
The physical demands described here are representative of those
that must be met by an employee to successfully perform the
essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
• Ability to sit and stand for long periods of time.
• Carrying, handling and reaching for objects.
• Manual dexterity to operate office equipment i.e. computers,
• Access to transportation to attend various meetings held in
proximity to the client offices.
• Able to fly to various meetings at investigator, vendor or
regulatory agency sites.
• Some international travel may be required.
Hi, my name is Sarwan Kumar
Let me know if you have questions
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