Clinical Data Manager

About Collabera:

Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace.

With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including.

• Collabera awarded Best Staffing Company to work for in 2012 by SIA. (hyperlink here)

• Collabera listed in GS 100 - recognized for excellence and maturity

• Collabera named among the Top 500 Diversity Owned Businesses

• Collabera listed in GS 100 & ranked among top 10 service providers

• Collabera was ranked:

• 32 in the Top 100 Large Businesses in the U.S

• 18 in Top 500 Diversity Owned Businesses in the U.S

• 3 in the Top 100 Diversity Owned Businesses in New Jersey

• 3 in the Top 100 Privately-held Businesses in New Jersey

• 66th on Fin Tech 100

• 35th among top private companies in New Jersey

Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.

Position Title:

Clinical Data Manager

Location:

Irvine, CA USA 92618

Duration: 12 months (Strong Possibility of Extension)

SUMMARY OF POSITION:

• As a key member of the Global Medical Affairs team representing our client's Clinical Operations, this person has responsibility for:

• Member of clinical research team responsible for data management activities across multiple trials.

• Main responsibility includes design of Case Report Forms, development of edit check specifications, creation of test scripts and testing of study database, query processing, data reporting, putting in place data management plans, timelines and manage multiple projects through closeout and archiving.

• Activities also include assisting/leading with study start-up activities like training sites, internal users and attendance in clinical project meetings.

ESSENTIAL FUNCTIONS:

• Perform data management activities on both Electronic Data Capture (EDC) and paper studies. Major activities include

• Performs as lead data manager for projects and/or programs

• Responsible for the design and development of Case Report Forms (CRF) in collaboration with CRAs or Clinical Project/Program Managers.

• Work closely with clinical project team and database programmers to provide edit check requirements and specifications at the time of study database development and Post production changes.

• Ensure study data quality by CRF data review, preparation for entry, query processing, discrepancy management, ad-hoc reporting, listing generation.

• Create and maintain all essential data management documentation including, but not limited to, data management plans, Data Review guidelines, CRF completion guidelines, Data Entry guidelines, UAT plans and other study specific work instructions or guidelines for multiple projects.

• Perform study user acceptance testing and database QC.

• Collaborate with CDMs and other staff as necessary

• Act as a point of contact with vendors such as Database developers, coders, Safety personnel, QA, Core Labs, etc.

• Assist in overall project tasks such as process flowcharts, Standard Operating Procedures (SOP), work instructions, training guidelines, etc.

• Participate in project meetings to give a status update to project managers and upper management.

• Collaborate with Medical coder to ensure accurate and consistent clinical reporting of clinical terms to assign a validated terminology in prep for analysis and reporting to regulatory authorities

• Ensure good Clinical Data Management practices to support data…