Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Clinical Data Management Lead

Expired Job

Fahrenheit IT Wilmington , DE 19801

Posted 2 months ago

Full Description:

One of our leading clients, a leading health services research firm headquartered in Wilmington, DE is seeking an experienced Leading Clinical Data Management Lead to join our team in our Wilmington, DE providing oversight of both the client's Electronic Data Capture (iMedNet) system and Database lock per protocol timelines, as well as supporting the design of the electronic Case Report Forms (eCRFs) for late phase research studies.

This role is a renewable contract opportunity with a company that has an excellent track record of extending contracts in order to retain top talent.

Please find the qualifications and requirements below. If you feel that this position is one that you are excited about and qualified for, please send over your most recent CV. We are always interested in talking to candidates for current AND future opportunities! Please respond directly at with your resume attached

  • WORD document

This opportunity is a temp-to-hire based on W2, 1099 or Corp-to-Corp. We also have other many other openings in our Pharmaceutical/Biotechnology/Medical Device group. If you are interested in aligning with a highly regarded organization that values quality and integrity and fosters an environment where teamwork and professionalism thrive, then don't hesitate to contact Rose Chu, VP in Pharmaceutical & Biotech Services Group at # for questions.

The primary role of the Clinical Data Management Lead is to:

  • Provide oversight of both the client's Electronic Data Capture (EDC) system and Database lock per protocol timelines

  • Supporting the design of the electronic Case Report Forms (eCRFs) for late phase research studies.

  • Supporting the data collection efforts in study types such as Patient/Provider Surveys, Focus Groups and Medical Record Abstraction studies.

Responsibilities include:

  • Represents the data management functions in client-facing and internal meetings.

  • Provides data management input to proposals and protocols.

  • Contributes to budget content and lead initial budget build of the data management scope.

  • Develops and manages timelines for key data management deliverables in coordination with the various area functional leads.

  • Monitors vendor performance to ensure timelines and data quality standards are met.

  • Reviews and approves key clinical data management deliverables, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, and electronic data transfer agreements.

  • Reviews final versions of survey materials and medical record abstraction data collection forms for completeness and quality.

  • Performs UAT on all data collection mechanisms.

  • Oversees all data management activities, database cleaning and lock activities including developing data management plans, supervising database development and reviewing and processing data to ensure completeness, accuracy and consistency of all databases.

  • Develops or updates clinical data management Processes, Guidelines and Standard Operating Procedures (SOPs).

  • Provides mentoring and training to Data Management staff.

  • Acts as escalation point for issues arising from site startup data collection through database lock.

  • Assigns Data Associates to studies and sites based on experience, geographic location, and time coverage.

  • Regularly review metrics reports to ensure quality and timeliness with the scope of work, and identify out of scope activities.

  • Monitors overall study progress daily/weekly and proactively develops or adjusts plans as needed to achieve targets.

  • Sound understanding of pertinent regulations such as ICH-GCP guidelines and 21CFR11.

Qualifications:

  • Requires BS degree in a life sciences field or relevant education and/or equivalent training in health services research, or a related field.

  • 7+ years of CDM Experience including Data Management Leadership and Late Phase Research experience.

  • iMedNet EDC experience preferred.

  • A solid understanding of late phase data management and how functions such as health economics, outcomes research, and epidemiology play a role in these studies.

  • Previous experience with claims data and clams databases is a plus

Search Terms: Clinical Data Manager, Lead Clinical Data Manager, CDM, Lead CDM, EDC, Electronic Data Capture, iMedNet EDC, iMedNet, database lock, design of the electronic Case Report Forms, eCRFs, late phase research studies, data collection, Medical Record Abstraction studies, Late Phase, data management, ICH-GCP, 21CFR11, Clinical Data Manager, Sr. Clinical Data Manager, Sr. Manager, CDM, clinical Data Management, Lead Clinical Data Management, Senior CDM, Lead CDM, Sr. CDC, Lead Clinical Data Associate, Senior Clinical Data Analyst, claims Data, Clams databases, ate phase data management, health economics, outcomes research, epidemiology

We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc-Lead CDM) in the subject line of your correspondence to ensure review.

Please forward your credentials in Word format through Indeed or call Rose Chu at for questions. Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.

Rose Chu

Vice President

  • Pharmaceutical, CRO, Biotech, Medical Device

Global Employment Solutions/Fahrenheit IT

P C F )

One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004

We're looking for hot talent! Tell your friends and get $250 plus a new iPad 2, iPad Mini, Apple Sport Watch or iPod Touch. Sign up!

ID: 153456

Skills:
Analyst, Biotechnology, CASE, Database, Data Collection, Development, Manager, Management, Materials, Medical Device, Metrics, Protocol, Protocols, Recruiter, Research
Permanent


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Workday Data Conversion Lead

Appirio

Posted Yesterday

VIEW JOBS 11/18/2018 12:00:00 AM 2019-02-16T00:00 Appirio, a Wipro Company helps customers improve Worker & Customer experiences with outcome-oriented consultants who bring the latest digital thinking and unmatched cloud experience. We create actionable strategies that deliver results quickly, and help organizations adapt to a new experience-driven era. We do this by harnessing the power of one of the world's largest crowdsourcing communities and thousands of pre-built solution accelerators. Appirio is a trusted partner to some of the world's largest brands, including YP, Cardinal Health, Coca-Cola, eBay, Facebook, Home Depot, Sony PlayStation, Moen, and IBM. Brief Summary of Role The Workday Data Conversion Lead will lead internal and global Workday data teams to transform and convert data and system configuration from the client's legacy system(s) into Workday. We are looking for experienced Data Conversion Leads. This position requires the ability to work as a team member, have regular interaction with customers, and the ability to maintain good working relationships between the team and the customer. The ideal candidate will be a self-motivated professional with a passion for data accuracy and completeness. This is an advisory and leadership role with responsibility for both client execution and team development. Responsibilities * Support Workday implementation teams by providing a full suite of high-quality data conversion services, including, but not limited to data collection and transformation, and configuration moves from tenant to tenant. * Collect and transform customer-provided data and functional configuration from the client's legacy system(s) into Workday. * Work directly with the functional and integration consultants to establish conversion approach, and complete the data conversion / load of customer data into Workday. * Become a functional data conversion expert in one or more Workday functional areas, such as HCM, Benefits, Payroll or Financials. * Assist customers with their data extracts, explaining the conversion process, defining data requirements, and working with them to correct data in their legacy systems to prepare for the data conversion cycle. * Ability to work well with both technical and non-technical resources. * Work in a fast paced, fast-growth, high-energy environment and deal with multiple high priority activities concurrently. * Seek ways to improve team efficiency by studying current practices and tools and implementing improvements with innovative solutions * Ability to mentor associate level consultants Education and Required Experience (Requirements) * B.S. degree in Business Systems, Human Resources, Computer Science/Information Systems; or equivalent combination of education and experience * 5+ years work experience in a related field (HR, Data Conversion, or equivalent). * Demonstrated on the job experience with ETL software, XML, Microsoft Excel, and Load Automation Tools. * Excellent listening skills to fully understand customer requirements and pain points. * Possess excellent presentation and communication skills, both verbal and written. * Proven ability to work independently in a results / deadline driven environment while still participating as a critical member of a large project team. * Enthusiastic, professional, and confident personality, with a focus on customer success. * Superior analytical, evaluative, planning, and problem-solving abilities. * Strong technical problem solving skills, with an ability to troubleshoot complex issues. * Driven by customer success with a team player attitude. * Located and able to work in the U.S. and able to travel 40% to 60% annually * Not eligible for visa sponsorship Appirio Wilmington DE

Clinical Data Management Lead

Expired Job

Fahrenheit IT