Clinical Data Entry Jobs

Required Knowledge, Skills, and Abilities (Proficiencies):

Required Experience, Education, Certification(s), License(s)

Preferred Experience, Education, Degree, Certification(s), License(s)

Associate Degree or BS in Health Information Management, Nursing or related field, preferred.

Extensive knowledge of medical terminology, human anatomy and physiology, and clinical disease process required.

Previous work experience in medical record abstraction activities preferred.

Support data management activities for multiple study protocols

Provide input on study-related documents, such as case report forms and data management plan

Review study-specific documentation to obtain understanding of study-specific data processing requirements

Collaborate with the Clinical Data Manager to develop manual review listing(s) and conduct manual review

Keep Clinical Data Manager informed of data status and issues

Minimum 1 year work experience, healthcare or clinical research setting preferred

With oversight from Lead Data Manager, issue and manage queries in the EDC database

Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.

Review protocols and apply protocol-specified guidelines to the structure, review, and cleaning of clinical data

Support study set-up, including EDC build (forms, edit checks, and study structure) and validation UAT testing

Build EDC forms from protocol or source document specifications

Build/program EDC edit checks from specification documents

Maintain to Caris and Site requirements for source document management and request for information.

Experience in both small and large scale project planning and reporting with strong communication and presentation skills.

Position requires 3-5 years of experience in data collection activities within a GCP/clinical research regulatory environment.

Knowledgeable in critical elements for success in clinical trials. GCPs, ICH, and Code of Federal Regulations.

Clinical study experience in the field of Oncology.

Experience in providing training for both internal and external staff with a mentorship approach for less experienced colleagues.

Excellent experience and organizational, communication, and demonstrated expert data management skills.

Manage delivery of projects through full data management process life-cycle.

Management of: Project timelines, Quality issues, Resource management, SOW (scope of work) / budget.

Provide data management expertise and data management process improvement to CDM management.

Mentor other team members in training and developing data management expertise.

Manage comprehensive quality control procedures.

Maintain compliance with job specific proficiency requirements, including CCT certification (RN or Paramedic may qualify)

This is a remote/work from home position, a strong internet connection will be necessary.

Support AT Clinical Operations by performing daily administrative responsibilities.

Provide feedback regarding any systems or concerns to the AT Clinical Operations Manager

Knowledge of medical terminology preferred.

Strong PC proficiency including working knowledge of Microsoft Outlook, Excel, Adobe, and PowerPoint

Minimum of 4+ years of relevant clinical data management experience in the pharmaceutical/biotech industries and college degree

Strong communication skills required, and experience working remotely is highly preferred

Experience performing clinical data review and data reconciliation, as well as handling review and reconciliation of data discrepancies

Good working knowledge of ICH, FDA, and GCP regulations and guidelines

Expertise working within the Medidata RAVE EDC system

Must be based on the East Coast and/or able to accommodate full East Coast working hours

Expected to have good working knowledge of Good Clinical Practices and Good Clinical Data Management Practices

Knowledge / Skills / Abilities:

Participates in internal/sponsor meetings and training programs, as required, working directly with the assigned project manager to provide data management support

Manages project resources according to budget and notifies project manager and supervisor of any potential out-of-scope requests from clients

Notifies project manager and supervisor of any potential out-of-scope requests or work issues that will affect project budget or timelines

Query and data entry rates considered acceptable per terms of contract

Demonstrated ability to set and implement plans to improve complex clinical data management processes and capabilities

Society of Clinical Data Management certification

Ensure that data management timeline and results are delivered to scope, cost, and time objectives

Define Lilly business requirements for the study/program for vendors to deliver

Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives

Demonstrated ability to effectively partner/influence a remote team and drive a technical project to deliver results

Knowledge of and prior experience in the domains of contract management, procurement, and/or performance reporting preferred.

Healthcare Revenue Cycle Management experience highly preferred.

Excellent negotiation and interpersonal skills, including experience with conflict resolution.

Highly proficient in Microsoft Office Suite (Outlook, Word, Excel, and PowerPoint), data analytics tools and document/calendar management.

Partner with and support cross-functional relationships with internal stakeholders including operations, quality assurance, client service, legal, compliance, and finance.

Excellent organizational and communication skills.

2+ years' experience extracting, collating, and generating reports required (preferably in a health setting)

1+ years' experience analyzing data for trends, patterns, and discrepancies required (preferably with clinical data)

1+ years' experience using data analysis software preferred

Track and trend patient information

Extract and integrate raw data to create actionable reports

Identify clinical data trends and patterns related to clinical outcomes

2. Maintains & builds awareness of internal and external clinical Data Management practices to enhance domain expertise

26. Excellent Technical skills, start-up knowledge is must

28. Project management & result orientation

3. Single point of contact for Study Data Manager / designee

16. Provide regular status reports to TCS Group Lead and Study Data Manager (SDM)

18. Communicate between different stakeholders and Study Data Manager (SDM)

Strong administrative skills and prior experience with data entry

Assist with large scale data entry, inputting relevant data into the database.

At least 2 years previous work experience in a clinical manufacturing environment

Sound knowledge of MS Office and computer literate

Fully remote anywhere in US

Please click ‘apply’ or contact Sam Chapple (Recruitment Manager, APAC) at Planet Pharma for more information:

Strong administrative skills and prior experience with data entry

Assist with large scale data entry, inputting relevant data into the database.

At least 2 years previous work experience in a clinical manufacturing environment

Sound knowledge of MS Office and computer literate

Fully remote anywhere in US

Please click ‘apply’ or contact Sam Chapple (Recruitment Manager, APAC) at Planet Pharma for more information:

Outstanding organizational and time-management skills with ability to multitask and prioritize

Provides cross-study support for data management activities

May attend study specific investigators’ meetings and other data management trainings

Supports the LDM with data management documentation filing

Excellent analytical and problem-solving skills

Strong interpersonal and communication skills

2 years data analysis, data analytics or database management

Understands and has experience with data warehouses, business analytics platforms, and database platforms.

Required Education: Bachelor's degree in Healthcare, Business, Information Technology or related field.

1 year of business intelligence and reporting experience

Clinical Decision Support; Microsoft Excel, Word, and PowerPoint Skills

Customer service skills; Written and verbal communication skills

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

High school diploma, G.E.D., or equivalent and three years of relevant experience or a combination of education and relevant experience.

Clinical knowledge in the field of oncology or blood and marrow transplantation

Basic knowledge of medical terminology

Excellent mathematical and analytical skills

Excellent communication skills, ability to relate effectively in person and work well in a team