myGwork - LGBTQ+ Business Community · 2 days ago

Senior Centralized Monitoring Analyst II

United States

Full-time

Remote

Senior Level

5+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

Internet

Insider Connection @myGwork - LGBTQ+ Business Community

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Serve as functional lead knowledgeable in RBQM methodologies, tools, processes, and central monitoring methods, tools, and systems.

Successfully influences study functional leads, with a focus on driving RBQM strategy, end to end data risk management and defining mitigations including proper monitoring strategy for critical-to-quality data and processes.

Ensures performance of assigned reviews with high quality, on-time results with more complex analyses or deeper root cause analyses to connect related signal to risks.

Provides training and guidance to junior team members.

Project leadership activities include: Leads the design and setup of study specific tools and centralized monitoring plan for data review; manages review timelines, develops analysis assignments for team, and supports budget management; organizes, communicates with internal team, and delegates as appropriate to ensure reviews are completed on-time, on budget, with high quality; assists with report development, delivers reports, and leads centralized monitoring meetings; contributes to risk assessment through the completion of the department risk assessment tools. Participates in the cross-functional risk assessment review meetings and contributes to overall risk planning and monitoring strategy.

Specialist activities included focused efforts on the development of new tools and analyses within area of specialty.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical monitoringData managementBiostatisticsRegulatory guidelinesSOPsClinical trialsMS OfficeComputer skillsProject managementProtocol understandingSubject matter expertCentralized monitoring planProblem-solvingAttention to detailAnalytical skillsJudgmentFlexibilityAdaptabilityConfidentialityCommunication skillsTeamworkLeadershipPrioritizationClinical Trials Support

Required

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years'). Prior experience in clinical monitoring, data management, biostatistics or related field in support of clinical trials is preferred.

Capable of applying in-depth knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations

Strong attention to detail and skill with numbers

Substantial analytical /problem-solving skills /judgment in decision making

Ability to work independently and organize and coordinate activities across the team

Demonstrated ability to maintain a high degree of confidentiality with clinical data and client's proprietary data

Proven flexibility and adaptability

Ability to work and lead in a team environment and independently

Strong oral and written communication skills (English) with the ability to communicate effectively with a variety of internal and external customers, including project team, functional management and client contacts

Strong computer skills, with solid knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems

Complete ability to extract pertinent information from standard study documentation, such as protocols, electronic study data systems and to identify trending of site/study data

Solid prioritization skills with ability to plan, monitor and manage workload fluidly in response to changing project demands

Comprehensive understanding of project protocol, project documentation including Centralized Monitoring Plan and other functional plans

Ability to serve as a subject matter expert and lead on projects cross-functionally