Clinical Data Associate Job Description

Clinical Data Associate Job Description

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Clinical data associate provides oversight for Data Management CRO and other third-party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.

Clinical Data Associate Duties & Responsibilities

To write an effective clinical data associate job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical data associate job description templates that you can modify and use.

Sample responsibilities for this position include:

Champion development and implementation of clinical data standards
Exhibit expert-level knowledge of clinical data standards
Stay abreast of global industry and regulatory requirements regarding clinical data standards
Lead the identification, review, evaluation, and implementation of new technologies related to clinical data standards
Will develop and maintain processes that align clinical data review activities across all applicable functions
Represents Clinical Data Review on cross-departmental projects and continuous improvement initiatives and other ad hoc multidisciplinary teams as required
Set up and maintain clinical activities using project tracking tools by coordinating with and supporting clinical teams
Obtain and track trial specific information according to clinical development plans
Prepare clinical planning and tracking databases of in-house and third-party trials according to protocol/data collection specifications and timelines
Identify and correct discrepancies in various tracking systems

Clinical Data Associate Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Data Associate

List any licenses or certifications required by the position: SCDM

Education for Clinical Data Associate

Typically a job would require a certain level of education.

Employers hiring for the clinical data associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Medical, Management, Education, Allied Health, Computer Science, Life Sciences, Life Science, Nursing, Science, Pharmacy

Skills for Clinical Data Associate

Desired skills for clinical data associate include:

Medical/clinical terminology
GCPs and applicable SOPs
Medical/clinical trial terminology
Clinical data
ICH/Good Clinical Practices
Good Clinical Practices and applicable Standard Operating Procedures
Microsoft Office and the ability to learn various programs
Medical terminology
Applicable internal
External and regulatory requirements/expectations to data deliverables

Desired experience for clinical data associate includes:

Support local medical organizations and clinical teams with planning and tracking database functionality and trial specific queries
Assist Operations Team members in performing high level analysis of TA clinical deliverables/timelines and highlight areas of concern
Assist with compiling and monitoring TA level performance metrics
Identify and provide input to process improvements
Accurate and timely set up in clinical planning and tracking databases of in-house and third-party trials according to protocol/data collection specifications and timelines
Coordinate with trial teams to ensure systems are accurate and updated within specified deadlines

Clinical Data Associate Examples

1

Clinical Data Associate Job Description

Job Description Example
Our company is hiring for a clinical data associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical data associate
  • Provide DM infrastructure support as needed
  • Act as thought leader to peers, team members, and other staff
  • Develop solutions and share best practices
  • Ensure effective communication and collaboration between CDSI and other functional groups impacted by data standards
  • Review and evaluate clinical patient data
  • Assist with the creation and validation of electronic case report forms and edit checks for their assigned studies
  • Use a study specific Data Management Plan
  • Perform serious adverse event reconciliation
  • Review treatment information, evaluate response to treatment, and ensure follow-up and survival data are accurately coded and updated
  • Work with the Study Chair to perform final case review
Qualifications for clinical data associate
  • Ability to work independently in a group setting
  • Strong working knowledge of SDTM or ADaM, CDISC Controlled Terminology, creation of data specifications, and annotated CRFs
  • Ability to think strategically, develop novel processes, and be comfortable working with or developing new systems or technology
  • Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data standards
  • Bachelor's degree, preferably in life sciences, computer science, or related discipline
  • Oversee and participate in all data management activities for multiple clinical development programs, such as vendor evaluation, CRF development, database specifications, user acceptance testing, query resolution, data review and data base lock
2

Clinical Data Associate Job Description

Job Description Example
Our company is growing rapidly and is hiring for a clinical data associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical data associate
  • Assist the study chair and statistician with the preparation of the database for analysis
  • Perform comprehensive quality control procedures on own work review the work of others when required
  • In addition they will be expected to perform data management activities such as Serious Adverse Event and Third Party Vendor reconciliations Data Listing reviews
  • Evaluates personnel development and training needs
  • Create departmental metric reports and facilitates interpretation of metric information
  • Performs internal audits and quality control of data in clinical database database system security and usage
  • Reviews data listings for accuracy and consistency of data
  • Identifies, resolves, and updates data discrepancies
  • Assists in implementing routine clinical research projects and standards
  • Communicates and escalates project level issues including processes, timelines, resourcing, performance, and establish appropriate course of action with Senior Management
Qualifications for clinical data associate
  • Participate in the data preparation for the NDA/EMA submission
  • Recruit and train high performing data management staff
  • Previous NDA/EMA experience is desired
  • Good written/ verbal communication skills with a strong command of English language and grammar
  • Articulate the flow of data (structure and format) from patient to analysis and apply this knowledge
  • To data solutions
3

Clinical Data Associate Job Description

Job Description Example
Our growing company is looking to fill the role of clinical data associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical data associate
  • Ensure efficient DM processes and update/maintain SOPs
  • Manage and supervise DM personnels and ensure their career growth
  • Overseeing DM operation to ensure quality and timely delivery of DM services
  • Assist BD for DM related business development activities
  • Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, to identify industry best practice and increase the visibility of Takeda
  • Provides leadership by attracting and retaining top talent, developing team members and ensuring organizational effectiveness, transparency and communications
  • Coordinates with other Operations Functional Leaders, Value Stream Leads and colleagues to ensure alignment of departmental roles and responsibilities
  • This position influences managers in decisions in terms of performance management of direct reports as appropriate and understands and aligns with long-term business and development needs
  • Can Serve as a business owner for processes/systems of medium/high complexity and/or significant departmental or cross-functional impact
  • Provide oversight on standard processes for registries and timelines for assigned programs of study teams
Qualifications for clinical data associate
  • Statistics, PK, Operations, Medical)
  • Bachelor’s degree or educational equivalence in computer, life sciences or a related field, or a related field
  • With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadership
  • Bachelor's degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing
  • Bachelor’s degree preferably in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualification
  • Min of 1 year Data entry experience
4

Clinical Data Associate Job Description

Job Description Example
Our company is looking for a clinical data associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical data associate
  • Serve as Subject Matter Expert (SME) for and oversees the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs using and electronic data capture (EDC) system and/or other data collection systems
  • Support Clinical Data Scientists for clinical trials in activities related to ensuring high quality, on-time data management deliverables
  • Participate in the design, documentation, testing and implementation of clinical data collection tools using an electronic data capture (EDC) system and/or other data collection systems such as electronic patient reported outcome (ePRO)
  • Assist the senior team members or liaise with customers to ensure compliance with submission deadlines
  • Assist with Acquisition Assessment of Registry health for products/programs acquired through mergers and integrations
  • Assist with Divestiture activities related to Registries, based on IND/IDE and sNDA/NDA/MMA transfers
  • Collaborate with study teams to complete Standard Maintenance updates
  • Collaborate with study team to draft Maintenance updates due to Protocol Amendments and Initial Protocol Registrations
  • Collaborate with study teams to ensure harmonization of data across global registries as applicable
  • Compile and maintain registry submission related documentation in internal systems on a timely basis
Qualifications for clinical data associate
  • Demonstrated ability to successfully manage people/teams within and across functions, showing the adaptability required to deliver value-added results in a complex environment
  • Demonstrated ability to effectively communicate ideas/concepts and to motivate others to accomplish challenging goals and objectives, frequently within aggressive timelines
  • Well-versed in analytical and conceptual capabilities
  • Demonstrated ability to effectively manage book of work and allocate resources to achieve maximum results
  • Thorough knowledge of global regulatory and guideline (inclusive of ICH GCP) requirements with clinical experiences in a drug development capacity
  • Demonstrated ability to build and maintain strong relationships across organizational and/or geographic boundaries through participation in cross-functional teams/initiatives
5

Clinical Data Associate Job Description

Job Description Example
Our growing company is looking to fill the role of clinical data associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical data associate
  • Provide review and feedback on applicable submissions to external Partners/ Collaborators based on Registry requirements
  • Provide guidance and expertise in the requirements of global registries and data disclosure commitments
  • Lead and contributes to specific initiatives regarding global registries
  • Support the development of cross-functional processes to ensure that Registry deliverables are aligned with disclosure standards
  • Assist with the review of other functional area's SOPs, WIs, and other departmental guidance documents
  • Identify opportunities for new or revised processes to be developed regarding global registries
  • Contribute to efforts to develop new or revised Registry processes
  • Contribute to continuous improvement initiatives such as process revisions, system testing, training, task forces and internal and external committees
  • Support junior team members
  • Assist in implementing routine clinical research projects and standards
Qualifications for clinical data associate
  • Bachelor Degree in the biological sciences or related disciplines in the natural science/health care field
  • Experience with Data Management practices and relational database management software systems preferred
  • A bachelor’s degree or higher in life sciences, biotechnology, computer programming or other relevant field
  • In some cases, a demonstration of applicable technical and behavioural competencies, and a combination of education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
  • Significant ability to creatively solve problems in a cross-functional setting
  • Experience in CRO oversight is highly desirable

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