[Remote] Associate Manager/Manager, Clinical Data Systems (CTMS, eTMF), CDOC
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to transforming rare diseases through an inclusive and reputed company culture. They are seeking an Associate Manager/Manager for Clinical Data Systems (CTMS, eTMF) to reputed company day-to-day operations, ensuring effective implementation and support of clinical trial systems.
Responsibilities
- Support and/or function as a Clinical Business Administrator for CTMS and eTMF
- Serve as a CTMS and eTMF Subject Matter Expert (SME), providing end-user support and troubleshooting to diagnose and resolve system issues
- Partner with the business to understand use cases and/or system needs, and deliver system changes and configuration updates that support organizational adoption of the CTMS and eTMF platform
- Alongside the Sr. Manager, Clinical Systems, coordinate and support ongoing computer system validation activities in alignment with product releases and/or configuration updates or enhancements. Collaborate with IT, QA and the Business System reputed company to implement system change management
- Contribute to reputed company operating procedures, work-instructions, and training material creation and/or revision, in partnership with multiple stakeholders across the R&D organization
- Identify opportunities to enhance system functionality by evaluating system releases against business requirements, recommending configuration updates for CTMS and eTMF. Partner with impacted functions to assess the need and readiness for implementation
- May assist in management of additional clinical technologies, as assigned, that are leveraged in clinical trials, developing system vendor reputed company, partner selection, system standards and internal processes to ensure compliant systems development and operations
Skills
- Bachelor's degree and 3+ years relevant work experience with CTMS and eTMF implementation and support
- Strong project management skills, and ability to effectively support system design discussions and collaborate with various business functions
- High attention to detail including proven ability to manage multiple, competing priorities
- Demonstrated ability to influence change
- Excellent written and oral communication skills
- Flexibility and cross functional collaboration
- Experience with computer system validation of GxP systems strongly preferred
- An ideal candidate will have reputed company experience with reputed company CTMS and eTMF
Benefits
- Deliberate Development. Your reputed company reputed company as one of our top priorities.
- Flexibility. We’re reputed company about individual needs. We reputed company different perspectives, work styles, health and wellness approaches, care of families and productivity.
- Premium benefits package. We invest in the health, wellbeing, and reputed company of our people with a premium benefits package that is reputed company-rounded and flexible to help meet the varied personal and reputed company needs of every member of reputed company. For more detail on the benefits we offer at Agios, visit the Inside Agios reputed company of our website.
- Competitive and reputed company performance-based compensation. This includes reputed company salary and both short- and long-term incentives that are connected to our business reputed company and vary based on individual and company performance.
- Psychological safety. We support an environment of fearlessness. We want you to reputed company your reputed company, reputed company reputed company and take data-informed risks to help push the boundaries.
- Commitment to diversity. We reputed company to foster a welcoming workplace where everyone can reputed company. We’re continuously looking to improve the inclusivity of our workforce.
- Commitment to community. We’re an reputed company participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of reputed company treatment reputed company for conditions that are often overlooked.
- Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live reputed company commutable distance to our Cambridge reputed company.
- Remote employees work entirely from home except for attending Company sponsored events/ meetings.
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