Clinical Data Manager Job Description template and pdf with duties [2024]

Job summary 1

The Clinical Data Manager participates in the clinical data management activities for a project within a data management project team; including the processing of case report form (CRF) and electronic data by Company SOPs, Good Clinical Practice, ICH Guidelines, and sponsor requirements.

Duties & Responsibilities 1

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Requirements & Skills 1

Job summary 2

We are looking to hire a Clinical Data Manager. This individual will be responsible for providing timely professional management of Data Management deliverables and clinical trial data concerning quality, timelines, and costs for assigned trials.

Duties & Responsibilities 2

Provide feedback to assure well-developed databases and data validation setup and execution while making the best use of standards and best practices
Support the team through database build requirements and complete startup activities for the study including building the eCRF, completion guidelines, standard and simple rules, data validation plan, and user acceptance testing (UAT); can lead a study in sequence under PCDM supervision.
Set up and Manage external data by protocol requirements, process, and validation requirements
Perform DM maintenance and validation activities during the study time and with quality.
Track and report status and progress for assigned trials and projects. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).
Communicate status updates and study-level information to the Trial Data Manager (TDM) and Program Clinical Data Manager (PCDM)
- Provide support to business users and teams on their use and support the implementation of the Clinical Data Standards strategy.
- Ensure adherence to GCP, DM standards, SOPs/procedures, job aids, and guidelines
- Maintain up-to-date, knowledge of relevant technologies (EDC, software languages, applications, etc.), Industry Standards (e.g. CDISC, define.xml, eCTD, etc.), and regulatory guidelines.

Requirements & Skills 2

Bachelor’s Degree or equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
The ability to fluently read, write, understand, and communicate in English
2 Years of Relevant Experience

Job summary 3

The Clinical Data Manager will provide leadership, management, and technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate, and timely manner to the Sponsor’s satisfaction.

Duties & Responsibilities 3

Requirements & Skills 3

To have the ability to train new staff and to monitor their performance.
- Proven project delivery skills.
- Several years of experience within Data Management or associated field.
- Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience Promotion to the next level is not automatic based on years of experience.

Job summary 4

We are seeking an experienced Clinical Data Manager to join our team. In this role, you will work within Clinical Affairs teams to manage and ensure the integrity of clinical study data from start-up through close-out and database lock. We are open to qualified candidates working remotely from home, anywhere in the United States.

Duties & Responsibilities 4

Requirements & Skills 4

Bachelor's degree OR a minimum of 4 years of data management experience
A minimum of 2 years of Clinical Data Management experience in the medical device, life sciences, or pharmaceutical industry
Expertise with MS Word, Excel, PowerPoint
Strong organizational skills, flexibility, and attention to detail
- Highly effective verbal and written communication skills
- Successful experience working independently and on cross-functional teams
- Ability to travel up to 5%

Job summary 5

Under close supervision, the Clinical Data Manager will lead all aspects of the clinical trial data management process from pre-study start-up to post-database lock for assigned projects.

Duties & Responsibilities 5

Collaborate with clients and team members to develop Case Report Forms (CRFs) and methodical data-cleaning strategies to support protocol endpoints.
Be involved in the Electronic Data Capture (EDC) clinical database development and user acceptance testing (UAT).
- Actively cleaning data, managing CRF and query trends and data reporting to ensure a clean database lock ready for analysis.
- Work alongside key functional areas (such as Project Management, Biostatistics, Medical, Clinical, Safety, Quality Assurance, etc.).
- Standard Operating Procedures / Work Flow Tools (SOPs/WFTs); regulatory directives; study specific plans and guidelines will be followed.

Requirements & Skills 5

Minimum Required: Bachelor's degree or in-country local equivalent or equivalent-related experience
Minimum 2 years experience for CDM I utilizing various clinical database management systems
Broad knowledge of drug, device, and/or biologic development and effective data management practices
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
Excellent organizational, interpersonal & leadership skills
Professional use of the English language; both written and oral
- Experience in a clinical, scientific, or healthcare discipline. Understanding of CDISC standards (CDASH, SDTM, etc.).
- Academic concentration in one or more of the following, or related disciplines; life sciences, computer science, or engineering.
- Advanced degree in clinical data management, health informatics, biometrics, or similar.

Job summary 6

The Clinical Data Manager will be responsible for leading and managing all data management activities related to the planning, execution, collection, and cleaning of clinical trial data. This position will assist with the final delivery of data for clinical study reports, publications, and regulatory submissions. This role will also be responsible for the oversight of outsourced data management activities.

Duties & Responsibilities 6

Requirements & Skills 6

BS/BA in Biological Sciences, Life Sciences, or healthcare required.
5+ years’ data management experience in biotech, pharma, or CRO setting
Working knowledge of Good Clinical Practices (GCP), ICH, and US and international regulations.
Ability to travel to the corporate office, investigator meetings, and CROs as needed
Organized and detail-oriented
- Strong communication skills in a compact clinical team working with aggressive timelines
- Experience with electronic data capture
- Computer skills (MS Office products, word processing, spreadsheets, etc.)

Job summary 7

Clinical Data Manager is responsible for reviewing and evaluating clinical data generated from the imaging portion of sponsor clinical trials conducted in various therapeutic areas.

Duties & Responsibilities 7

Requirements & Skills 7

Job summary 8

We are seeking a highly motivated individual to join us as a Clinical Data Manager. This individual will work with the Biostatistics, Programming, and Clinical Operations teams in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Senior Manager, Clinical Data Management. The Clinical Data Manager will be responsible for overseeing all aspects of external data management for the Company’s clinical development programs with guidance from the Senior Manager, CDM. This position will be responsible for clinical data collection and data review. The Clinical Data Manager will also work with Clinical Operations, Safety, and Regulatory as necessary.

Duties & Responsibilities 8

Project-level coordination and day-to-day oversight of External Data Management tasks
Manage data management timelines to ensure the goals of teams are met
Manage vendors and ensure appropriate resources are available to meet the demands of the assigned clinical trials
Provide CDM expertise for external vendor data coordination, collection, and cleaning to efficiently ensure high-quality data
- Manage CDM deliverables in coordination with internal and external cross-functional teams
- Review clinical data on an ongoing basis to ensure quality data
- Create Data Transfer Plans and other pertinent External Data documentation

Requirements & Skills 8

BS/BA in life science or related discipline and 7+ years of experience in Data Management OR
MS/MA in life sciences or related discipline and 5+ years of experience in Data Management
Bachelor’s with 7+ years of experience in CDM within clinical development or Master’s with 5+ years of experience in CDM within clinical development
Scientific background and experience with lab data handling
Demonstrated knowledge of FDA, EMA, and ICH guidelines and regulations covering clinical trials, statistics, and data management
- Experience managing clinical data management deliverables for regulatory filings
- Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
- Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks

Job summary 9

The Clinical Data Manager is an individual contributor role that provides Data Management support for assigned program(s). The Clinical Data Manager is a self-motivated, collaborative clinical data management professional who is a self-starter that thrives in a fast-paced environment.

Duties & Responsibilities 9

Work with Clinical Data Management (CDM) Lead to support operational activities for one or more programs.
Monitor data management vendor quality of work through important performance metrics.
Maintain program-level DM deliverable timelines following program development strategy. Escalate timeline issues.
Support data management at cross-functional team meetings providing accurate study status updates, escalation of data management issues
Draft eCRF design and edit check specifications; support cross-functional review.
Perform cross-functional sponsor EDC user acceptance testing.
- Work with external data vendors to develop data transfer agreements.
- Support implementation of essential metrics reports/listings.
- Draft and review DM essential documents including annotated CRFs, eCRF Completion Guidelines, Clinical Data Management Plans, and DB Go Live and Lock documentation.

Requirements & Skills 9

10+ years of clinical trial data management experience in the pharma/biotech industry.
Extensive technical experience using electronic data capture systems. Demonstrated experience with Oracle Inform.
In-depth knowledge of DM industry standards, best practices, and CDISC/CDASH implementation.
Ability to adapt and manage to compete and rapidly changing priorities.
Identifying issues and supporting teams in the development of creative solutions and compliant decisions.
- Demonstrate excellent verbal/written and interpersonal skills required to effectively communicate and collaborate in a cross-functional team environment.
- Ability to work independently and dependably meet project timelines.
- Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, Project, and Outlook).

Job summary 10

The Clinical Data Manager is required to manage clinical research data in the department of Clinical Research studies. He or she is responsible for the updating, maintenance, and validation of clinical study databases and for the provision of computerized reports of these data. He or she is a key member of the clinical project team and should be able to prioritize work in line with project management decisions. The responsibilities of the Clinical Data Manager are to manage clinical trials through the review, cleaning, and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines, and regulatory agency guidelines.

Duties & Responsibilities 10

Review, analyze, and validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines
Review and approve CRF design, data review ground rules, and database design according to Standard Operating procedures and protocol
Assist in standardizing data management procedures such as documentation for departmental operating procedures
Develop and maintain documentation and data management guidelines
Maintain clinical trial data accuracy through review of case report forms for completeness and consistency
- Assist in the development and implementation of strategy for data cleaning and in the design and programming of clinical databases
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures, client guidelines, and regulatory agency guidelines
- Generate data retrievals and summaries

Requirements & Skills 10

Bachelor’s degree in scientific or relevant discipline
At least 4 years of experience in the Clinical Research Industry and Clinical Data Management.
Knowledge of relevant GCP regulations and pertinent ICH guidelines
Strong interest in clinical research and have an affinity with working with databases
Experience with a biopharmaceutical company, CRO, or academic setting
- Experience with clinical trial electronic data capture systems and processes is an asset
- Experience with clinical drug development process and knowledge of FDA regulatory requirements
- Experience with multi-site and multiple clinical trials supply support globally

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