Clinical Trials Manager KATALYST HLS

Job Requirements:
BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
Seven or more years of relevant clinical trials experience, with at least four years of experience as a travelling CRA in the pharmaceutical industry
1+ years of trial management experience
Experience in CNS required
Travel required up to 20-25% of the time
Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
Demonstrated ability to work independently and in a team environment


Senior Lead Data Manager KATALYST HLS

Job description:
Oncology Business Unit – Medical & Data Management. Data management serves as key subject matter expert on topics related to data management activities.
Contributions include, but are not limited: vendor selection and management, mentoring junior staff, training team members, ongoing data review and reconciliation, project data management.
Position Summary:
The Senior Lead Data Manager (Sr. LDM) leads and/or supports the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community.
The Sr. LDM may assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s/he serves as the primary contact for Oncology Data Management on the Core Study Team.

Clinical Trial Manager Katalyst HLS

Required Skills:
Manage the operational aspects of clinical trials
Participate in protocol, CRF development, Clinical Study Report preparation, as appropriate
Prepare metrics and updates for management, as assigned
Proactively identify potential study issues/risks and recommends/implements solutions
Participate in and facilitate CRO/vendor selection process for outsourced activities
Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (G


Project Manager (Regulatory affairs, Medical devices) katalyst HLS

Primary Responsibilities and Duties:
Determine and communicate deliverables and deadlines to business unit core project teams to ensure accurate expectation setting/planning, such as any required documentation, sample types and quantities needed, expected completion dates for any deliverables. In cases of expedited requests, work with the necessary group managers to agree on accelerated timeline/strategy.
Work with toxicologists and group managers to ensure test plans are developed to meet project goals. Create, organize, and maintain hard copy testing project files and electronic database.
Monitor progress of upcoming and ongoing projects. Provide customers, and internal management with progress reports and/or status updates. Promptly identify issues or delays and work with affected personnel to resolve issues and communicate any changes in strategy or timelines.


Senior Data Manager katalyst HLS

Execute all DM start-up and data back lock activities, including the development and maintenance of
Edit check and custom listing specifications
Data Management Plan
CRF Completion Guidelines
Conduct user acceptance testing of data outputs per DM specifications
Organize and actively participate in CRF review meetings with the client
Perform comprehensive hands-on data review of all patient data through query management and/or manual review in accordance with SOPs and Work Instructions.
Analyzes study data metrics to continually assess both data quality and study progress
Track and provide project status updates to project managers for monthly project team meetings
Coordinate with Quality Assurance team to resolve any QA data issues


Project Manager katalyst HLS

The project manager will be part of the Access Services Project Management Office (PMO).
The project manager is responsible for the effective management of cross functional project teams and the efficient governance of the project.
This includes planning, executing, milestone tracking, monitoring variances to plan and budget, reporting progress to stakeholders and ultimately ensuring all project milestones and objectives are successfully met.
The Project Manager is also responsible for utilizing resources in an efficient manner and maintaining a co-operative, motivated and successful team.


LIMS Program Manager job – Katalyst HealthCares & Life Sciences – Summit, NJ

March 2, 2018 – LIMS Program Manager – p b Summary: /b /p ul li The Program Manager role will be aligned with the GPDO, supporting the Portfolio Manager and the Business Partner(s) of