Responsible for entire data management process from study set-up to study close-out; primary ... projects. * Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems.
Quick apply
Responsible for entire data management process from study set-up to study close-out; primary ... projects. * Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems.
Share new industry standards and best practices with project and study teams and departments as ... Work with Data Managers and EDC Programmers to implement new or modified global library objects (e ...
Share new industry standards and best practices with project and study teams and departments as ... Work with Data Managers and EDC Programmers to implement new or modified global library objects (e ...
Share new industry standards and best practices with project and study teams and departments as ... Work with Data Managers and EDC Programmers to implement new or modified global library objects (e ...
Share new industry standards and best practices with project and study teams and departments as ... Work with Data Managers and EDC Programmers to implement new or modified global library objects (e ...
Edc Project Manager information
What is an EDC project manager?
EDC Project Managers are professionals who oversee the planning, execution, and monitoring of projects related to Electronic Data Capture (EDC) systems, primarily within clinical research and pharmaceutical industries. They coordinate between cross-functional teams, manage timelines, ensure regulatory compliance, and address any issues that arise during the data collection process. Their goal is to ensure that EDC systems are implemented efficiently and effectively, supporting the overall success of clinical trials. EDC Project Managers also act as the main point of contact for sponsors and stakeholders, ensuring that project objectives and quality standards are met.
What are some common challenges faced by EDC project managers when implementing new electronic data capture systems?
EDC Project Managers often encounter challenges such as ensuring seamless integration of the new system with existing clinical trial workflows, managing diverse stakeholder expectations, and maintaining data quality throughout the study. They must also handle tight timelines and adapt quickly to regulatory changes or sponsor requirements. Effective communication with both technical teams and clinical staff is crucial to overcoming these obstacles and ensuring successful project delivery.
What are the key skills and qualifications needed to thrive as an EDC project manager, and why are they important?
To thrive as an EDC Project Manager, you need expertise in clinical data management, project coordination, and a solid understanding of Electronic Data Capture (EDC) systems, usually supported by a degree in life sciences or related fields. Familiarity with EDC platforms like Medidata Rave or Oracle InForm, along with certifications such as PMP or CDISC, is highly valuable. Strong organizational, problem-solving, and communication skills help you effectively lead cross-functional teams and manage client expectations. These competencies ensure successful EDC project delivery, regulatory compliance, and high-quality clinical trial data.
What is the difference between Edc Project Manager vs Electrical Project Manager?
| Aspect | Edc Project Manager | Electrical Project Manager |
|---|---|---|
| Certifications | PMP, OSHA, EDC-specific training | PMP, OSHA, Electrical licenses |
| Work Environment | Energy, utility, and infrastructure projects | Construction, industrial, and commercial electrical projects |
| Industry Usage | Common in energy distribution and utility sectors | Common in construction and industrial sectors |
| Job Focus | Distribution systems, substations, and energy delivery | Building wiring, electrical systems, and installations |
The Edc Project Manager primarily oversees energy distribution and utility infrastructure projects, focusing on energy delivery systems. In contrast, the Electrical Project Manager handles a broader range of electrical construction projects, including commercial and industrial wiring. Both roles require similar certifications but differ in industry focus and project types.
Does Edc Project Manager offer remote work options?
The Edc Project Manager role may offer remote work options depending on the employer's policies. Many project management positions can be performed remotely, especially with skills in collaboration tools and virtual communication platforms. Candidates should verify specific job postings for remote work availability.
What are popular job titles related to Edc Project Manager jobs in Connecticut?
For Edc Project Manager jobs in Connecticut, the most frequently searched job titles are:
What job categories do people searching Edc Project Manager jobs in Connecticut look for?
The top searched job categories for Edc Project Manager jobs in Connecticut are:
What cities in Connecticut are hiring for Edc Project Manager jobs?
Cities in Connecticut with the most Edc Project Manager job openings:
Key responsibilities
Manage the entire data management process from study set-up to study close-out, including issue resolution.
Interact directly with clients and data management suppliers to coordinate project activities and ensure data quality.
Oversee and develop data management study documentation, including CRFs, validation specifications, and Data Management Plans.
Job description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
Roles and Responsibilities:
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
Roles and Responsibilities:
- Confidently displays excellent internal and external customer service.
- Has proficiency and knowledge of multiple EDC systems; applies this knowledge to advise customers regarding the best-fit EDC solution.
- Interacts directly and independently with DM suppliers including EDC and/ or IWR; expert communicator, where necessary negotiating with supplier to meet business needs.
- Interacts directly and independently with client to coordinate all facets of projects; expert communicator; builds and maintains strong client contacts and relationships.
- Responsible for entire data management process from study set-up to study close-out; primary contact on all data management study-specific issues; has high-level knowledge of drug development as it pertains to data management.
- Actively participates in protocol review with clients, providing suggestions regarding ability to capture protocol information in database successfully.
- Strong understanding of GCP/ ICH guidelines and FDA regulations, as applicable to data management.
- Creates training exercises; serves as mentor and trains new clinical data managers.
- Provides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data) with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits.
- Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan.
- Preparation of any study tracking and metric reports for use by the study team.
- Oversees execution of user acceptance testing (UAT) of study-specific systems and applications.
- Interacts with cross-functional team members to ensure completion of all timelines and studies.
- Participates in data management and/or organizational initiatives.
- Initiates SOP updates and provide specifications for DM systems/ tools and process enhancements.
- May act as resource for QC activities in collaboration with QC Coordinator.
- Understands and follows processes related to project management as appropriate for data management projects (e.g., updating PSS, close-out procedures, etc.).
- Confident, positive attitude displayed towards clients and projects.
- Willingness to learn new skills and expand knowledge of drug development.
- Leads data management projects with little management oversight.
- Ability to work independently and resolve issues.
- Ability to clearly articulate the DM services offered at company, including pros and cons of various DM approaches (specific to a client or operating model). To include potential attendance at (web or remote) capabilities and bid defense meetings.
- Bachelor’s or Master’s Degree in scientific or health care field preferred with industry or relevant experience.
- 5+ years’ experience in data management field with a minimum of 1 year of experience leading projects.
- Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems.
- Extensive knowledge of Clinical Operations SOPs and Working Practices.
- Excellent verbal and written communication skills, as well as, interpersonal and organizational skills.
Powered by JazzHR
MDSYUNtgD3
About M. M. S.
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
1 - 10 Employees
Headquarters location
Los Angeles, CA, US
Year founded
1980