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21 days old

Clinical Data Management & Technology (CDMT) Contractor V

Kelly Services
Cambridge, MA 02238
Kelly is hiring a **Clinical Data Management & Technology (CDMT) Contractor V** for one of our biotech clients


+ $90-116/hr

+ Remote

+ 1 year contract to start

+ must have strong CELL THERAPIES experience


OBJECTIVES:


Responsible for timely and high quality data management deliverables supporting the Takeda portfolio. Establish asset and study level strategies and services, including excellence in the application of standards.

Responsible for data management oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget

Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takedas obligations described in ICH-GCP and Takedas business objectives. Activities include from protocol synopsis through database release and submission

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 Takeda values.

Serves as a clinical data management expert and provides guidance on CDISC standards.


ACCOUNTABILITIES:

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 Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions.

Contributes influential leadership in collaboration with other Takeda Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.

Provides input to functional governance with Takedas strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.

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 forecasting.

Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of Takeda.

Participates and represents function in formal inspections and audits as requested.

Other duties as assigned


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:


Education:

BS/BA required preferably in a health-related, life science area


Experience:

Minimum of 8years data management and/or drug development experience.

Proven track record of strong project management skills and experience managing data management activities for large drug development programs

Experience with all phases of development and at least 2 therapeutic areas.

Ability to handle multiple development programs simultaneously.

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 and maintenance.

Good understanding of CDISC standards, and experience implementing standards.

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 tools.

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.

Able to influence without authority

Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills

Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo

Pragmatic and willing to drive and support change

Is comfortable with ambiguity

Embody a culture of continual improvement and innovation; promote knowledge sharing


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-28 Expires: 2021-06-28

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Clinical Data Management & Technology (CDMT) Contractor V

Kelly Services
Cambridge, MA 02238

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