The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for ...
The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for ...
The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for ...
The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for ...
Position Summary The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. Key Responsibilities ...
Position Summary The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. Key Responsibilities ...
Position Summary The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. Key Responsibilities ...
Position Summary The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. Key Responsibilities ...
Associate Director, Clinical Data Management
Bothell, WA ยท On-site
$190K - $205K/yr
Description ASSOCIATE DIRECTOR, CLINICAL DATA MANAGEMENT JOB SUMMARY TheAssociateDirector,Clinical Data Managementwill leadData Management for multiple clinical studies and/or a clinical development ...
Associate Director, Clinical Data Management
Bothell, WA ยท On-site
$190K - $205K/yr
Description ASSOCIATE DIRECTOR, CLINICAL DATA MANAGEMENT JOB SUMMARY TheAssociateDirector,Clinical Data Managementwill leadData Management for multiple clinical studies and/or a clinical development ...
Director, Clinical Data Management
Redmond, WA ยท On-site
$190K - $250K/yr
SystImmune is seeking an experienced and strategic Director, Clinical Data Management to lead the clinical data management function across our portfolio. This individual will be responsible for ...
Director, Clinical Data Management
Redmond, WA ยท On-site
$190K - $250K/yr
SystImmune is seeking an experienced and strategic Director, Clinical Data Management to lead the clinical data management function across our portfolio. This individual will be responsible for ...
The Director, Clinical Data Management, will be required to collaborate closely with other functional leaders to ensure clinical trial success. Defines project-level data management strategy.
The Director, Clinical Data Management, will be required to collaborate closely with other functional leaders to ensure clinical trial success. Defines project-level data management strategy.
Director, Clinical Data Management
Warren, NJ ยท On-site
The Director, Clinical Data Management provides strategic and operational leadership and oversight of data management activities to ensure the quality, integrity, consistency and inspection readiness ...
Director, Clinical Data Management
Warren, NJ ยท On-site
The Director, Clinical Data Management provides strategic and operational leadership and oversight of data management activities to ensure the quality, integrity, consistency and inspection readiness ...
Director, Clinical Data Management
Cambridge, MA ยท On-site
$197K - $266K/yr
Summary The Director, Clinical Data Management is responsible for the oversight of data management activities in support of Alnylam studies across all stages of clinical drug development. This ...
Director, Clinical Data Management
Cambridge, MA ยท On-site
$197K - $266K/yr
Summary The Director, Clinical Data Management is responsible for the oversight of data management activities in support of Alnylam studies across all stages of clinical drug development. This ...
The Director, Clinical Data Management, will be required to collaborate closely with other functional leaders to ensure clinical trial success. Defines project-level data management strategy.
The Director, Clinical Data Management, will be required to collaborate closely with other functional leaders to ensure clinical trial success. Defines project-level data management strategy.
This is an excellent opportunity for an experienced data management professional to take ownership of study-level DM operations and drive quality and consistency across our clinical program.Primary ...
This is an excellent opportunity for an experienced data management professional to take ownership of study-level DM operations and drive quality and consistency across our clinical program.Primary ...
Director, Clinical Data Management
Cambridge, MA ยท On-site +1
$197K - $266K/yr
Summary The Director, Clinical Data Management is responsible for the oversight of data management activities in support of Alnylam studies across all stages of clinical drug development. This ...
Director, Clinical Data Management
Cambridge, MA ยท On-site +1
$197K - $266K/yr
Summary The Director, Clinical Data Management is responsible for the oversight of data management activities in support of Alnylam studies across all stages of clinical drug development. This ...
We have an excellent opportunity for a Director, Clinical Data Management , to join our team. This position will be based out of our San Diego, CA. office and is a minimum 2 days a week onsite hybrid ...
We have an excellent opportunity for a Director, Clinical Data Management , to join our team. This position will be based out of our San Diego, CA. office and is a minimum 2 days a week onsite hybrid ...
The Director, Clinical Data Management provides strategic and operational leadership and oversight of data management activities to ensure the quality, integrity, consistency and inspection readiness ...
The Director, Clinical Data Management provides strategic and operational leadership and oversight of data management activities to ensure the quality, integrity, consistency and inspection readiness ...
Director, Clinical Data Management
New York, NY ยท On-site
$220K - $250K/yr
Syndax Pharmaceuticals is looking for a Director, Clinical Data Management At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax ...
Director, Clinical Data Management
New York, NY ยท On-site
$220K - $250K/yr
Syndax Pharmaceuticals is looking for a Director, Clinical Data Management At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax ...
Position Overview Prime Medicine is seeking an experienced Associate Director of Clinical Data Management to lead clinical data strategy and execution across gene editing programs from first-in-human ...
Position Overview Prime Medicine is seeking an experienced Associate Director of Clinical Data Management to lead clinical data strategy and execution across gene editing programs from first-in-human ...
Clinical Affairs Summary The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads all ...
Clinical Affairs Summary The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads all ...
The CDM leads all aspects of clinical data management from study planning to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer. The ...
The CDM leads all aspects of clinical data management from study planning to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer. The ...
Clinical Affairs Summary The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads all ...
Clinical Affairs Summary The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads all ...
Establish and manage data capture, management, and review standards to ensure the quality and integrity of clinical research data in compliance with global regulatory requirements. * Provide ...
Establish and manage data capture, management, and review standards to ensure the quality and integrity of clinical research data in compliance with global regulatory requirements. * Provide ...
Clinical Data Management Associate information
See salary details
$13.94 - $20.56
5% of jobs
$20.56 - $27.19
6% of jobs
$29.74 is the 25th percentile. Wages below this are outliers.
$27.19 - $33.81
35% of jobs
The median wage is $34.45 / hr.
$33.81 - $40.43
38% of jobs
$40.43 - $47.05
6% of jobs
$47.05 - $53.67
3% of jobs
$53.67 - $60.29
2% of jobs
$60.29 - $66.91
0% of jobs
$66.91 - $73.54
0% of jobs
$73.54 - $80.16
1% of jobs
$80.16 - $86.78
3% of jobs
$13
$38
$86
How much do clinical data management associate jobs pay per hour?
Which is better, CDM or SAS?
Is clinical data management a good career?
What does a clinical data associate do?
Is CRA an entry level job?
What is the difference between Clinical Data Management Associate vs Clinical Data Coordinator?
| Aspect | Clinical Data Management Associate | Clinical Data Coordinator |
|---|---|---|
| Responsibilities | Data entry, validation, database management, ensuring data quality | Oversees data collection, manages databases, coordinates data flow between teams |
| Required Skills | Attention to detail, knowledge of clinical data systems, basic understanding of regulations | Strong organizational skills, data management experience, communication skills |
| Work Environment | Clinical research labs, CROs, pharmaceutical companies | Clinical trial sites, research organizations, CROs |
| Common Usage | Entry to mid-level data roles in clinical trials | Data oversight and coordination roles in clinical studies |
The Clinical Data Management Associate focuses on data entry, validation, and database management, ensuring data accuracy. The Clinical Data Coordinator oversees data collection and flow, coordinating between teams. Both roles require similar skills and work environments but differ in scope and responsibilities.
Full-time
Medical, Dental, Vision, Retirement
Posted 20 days ago
Job description
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
Visit our website to learn more about our company and culture!
Site: www.ptcbio.com
Job Description Summary:
Job Description:
Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area.
The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position has a leadership role to proactively develop plans for the utilization of EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation.
She/He may have supervisory responsibilities for both internal staff and external consultants. They may also manage direct reports and work cross-functionally with various internal departments and external resources on Data Management related issues.
The Associate Director, Clinical Data Management, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
- Ensure the data collected meets the requirements of the study objective and company quality standards.
- Assist in the development and implementation of strategic vision for data management (DM) group.
- Collaborate with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
- Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to design and develop data collection instruments (e.g., eCRF's) to ensure the required information is captured for statistical analysis.
- Oversee coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding
- Lead data management activities, clinical database cleaning in EDC, data reconciliation with external vendor data, SAE reconciliation and lock activities.
- Lead development of data management plans, data review plans, supervise database development, and reviewing and processing of clinical trial data to ensure completeness, accuracy, and consistency of clinical trials data.
- Prepare and distribute or facilitate distribution of periodic reports of study status including, case report form (CRF) completion status, missing pages, query aging, clean patient tracker (CPT), etc.
- Participate in cross functional team meetings, as requested, and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.
- Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data.
- Develop and update SOP's and other documents associated with the data collection, handling, and review processes, e.g., Working Instructions (WI), Best Practices Documents (BPD)to meet regulatory compliance and operational needs.
- Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
- Mentor clinical team members by resolving problems and providing DM guidance.
- Manage multiple and varied tasks, prioritize workload with attention to detail.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team.
- Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities.
- Lead the completion of data management activities to meet project timelines and communicate status to respective team members.
- Contribute to the development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.
- May manage, coach, and mentor direct reports.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* Minimum level of education and years of relevant work experience.
- Bachelor's degree in science or related field (such as healthcare) and a minimum of 8 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
* Special knowledge or skills needed and/or licenses or certificates required.
- Experience in second-line management and functional leadership.
- Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (PRO) and other database technologies.
- Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages.
- Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.
- Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates, etc.).
- Strong verbal and written communication, decision-making, influencing, negotiation, and project management skills.
- Technical skills and experience using Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire, J-Review, Business Objects).
- Proficiency in the use of Microsoft Office Suite of tools (Word, Excel, etc.).
- Learning agility and 'scalability' to take on increasing responsibility Excellent time management, flexibility, ability to coordinate workload and meet established deadlines.
- Ability to influence without direct authority.
- Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
- Minimum five (5) years' experience with Medidata RAVE(EDC, R2DS/RBS, Architect).
- Experience with Medidata RAVE.
- Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience.
- Experience in PL/SQL, SAS, Java, C++ relational database design and database programming skills preferred.
* Travel requirements
- 5- 15%
Expected Base Salary Range
$163,800 - $206,200. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
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EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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About PTC Therapeutics
Sourced by ZipRecruiter
Industry
Manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Warren, NJ, US
Year founded
1998