Lead Clinical Data Manager Jobs

Experience with MDM (Master Data Management).

Data & Analytics leader with 15+ years of industry experience.

At least 5 years of experience with clinical trial domain experience is required.

Experience with modern cloud analytics platforms such as Snowflake and/or Databricks is required.

Some MDM experience will be highly desirable.

Experience with ADF (Azure Data Factory) will be desirable.

· Perform Data Management activities and support to internal and external project teams.

· Previous CRO experience is strongly recommended.

· Client facing experience is preferred, but not required.

· Excellent oral and written communication skills.

· Attention to detail, ability to prioritize and manage multiple projects with competing and aggressive timelines.

· Perform data cleaning activities including the development, review, and generation of queries and query tracking.

Multiple years’ CDM or other data analytics / data management experience, including experience leading small projects and project teams.

Acts as a point of contact for study management teams and for Clinical Development regarding data management issues.

Ensures adherence to standard business processes within CDM systems to assure compliance with regulatory requirements.

Trains and mentors less experienced in colleagues in CDM processes, projects, programs and tools.

Adheres to regulatory requirements, industry standards and Gilead SOPs and ensures the same across own team.

Demonstrates strong facilitation / presentation skills and ability to appropriately delegate tasks to others.

You will Oversee (and sometimes lead) the data management of Phase 1 through 4 clinical trials in a small development program

Represent Data Management on the Development Core Team and/or Clinical Trial Working Groups as appropriate

Provide direction and leadership in CRO and vendor selection and management.

Be responsible for and manage data management activity of Clinical Data Managers assigned to his/her trials

Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management, and Regulatory to ensure operational excellence.

Contribute to strategic planning to ensure optimized use of data management resources within the area of responsibility

Data Management experience in clinical trials

Oversee the data management procedures and designs for clinical trials

Support sponsor interaction activities from a data management perspective

Study start-up, study conduct, and study close-out experience

Interact cross-functionally to design and validate specification and edit checks for EDC systems

Assisting with studies within a TA from SSU to DBL

Allocate and prioritize workloads for multiple projects (media control, data entry, pre entry review and query management tasks)

Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process

Excellent organizational and project management skills

Technical skills including EDC systems, clinical data management systems, Microsoft Office

Serve as a primary or backup resource for issues pertaining to data management

Assist other Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities

Development and maintenance of data management documents (such as laboratory data management plan, Data Query Plan, and Data Transfer Agreements (DTAs))

Bachelor’s degree in life sciences or other relevant discipline, or equivalent domain experience required.

Good organization and planning skills.

Strong interpersonal skills and communication skills (both written and oral).

Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment.

Weekly sample status metrics and/or any other study specific metrics and reports

Receive world-class training of verbal intervention & physical management techniques

Responsible for reviewing case management documentation of CANS, MHA, Stabilization Plans, Individual Crisis Management Plans (ICMPs), and biweekly reports.

Starting pay $15.25 an hour! We pay for experience and education!

Consistently implement behavior management plans to reduce maladaptive behaviors

Enjoy eligible holidays at home while getting paid with our Paid Holiday plan

Responsible for direct supervision SAT/CNPCC BA Case Managers.

Develop and review data management procedures for clinical trials with sponsor companies and other departments;

Design reports and metrics that are useful management tools for your projects;

Attend and participate in teleconferences and face-to-face meetings with sponsor companies as the lead representative from data management;

May provide project data management training as needed regarding CRF Completion or EDC system usage;

Coordinate overall data management by serving as primary contact for the sponsor, external data providers, and all project team members

Manage multiple projects and associated project team members; and

Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process

Excellent organizational and project management skills

Technical skills including EDC systems, clinical data management systems, Microsoft Office

Perform/Manage study conduct activities including listing reviews, query management, data transfers etc.

Serve as a primary or backup resource to other Clinical Data managers for issues pertaining to data management on multiple studies

Assist Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities

Required experience as a clinical data professional with knowledge of clinical regulatory regulations and data management.

3 years of clinical research data management experience is required.

Assist the clinical research team in day-to-day operational activities of data management.

Support internal clinical data management initiatives.

Excellent communication and analytical skills, and a bachelor's degree in a related field.

Working knowledge of studies software is required.

Bachelors + 4 Years Data Management Experience OR Masters and 2 Years of Data Management

Develop and review data management procedures for clinical trials with sponsor companies and other departments;

Design reports and metrics that are useful management tools for your projects;

Attend and participate in teleconferences and face-to-face meetings with sponsor companies as the lead representative from data management;

May provide project data management training as needed regarding CRF Completion or EDC system usage;

Coordinate overall data management by serving as primary contact for the sponsor, external data providers, and all project team members

Documented IVD management experience (Team lead, manager, other leadership title)

Knowledge of end-to-end data management activities in various IVD clinical studies

Expertise in working with Electronic Data Capture (EDC) systems and clinical data management systems like Medidata Rave and Medrio.

Bachelor’s Degree with at least 3 years’ relevant work experience as a Manager, Clinical Data Team

Experience working as Lead (3+ years) or Senior Data Manager (1+ years) in the IVD space.

Reports to the Senior Manager or Director level professional

Excellent experience and organizational, communication, and demonstrated expert data management skills.

Manage delivery of projects through full data management process life-cycle.

Management of: Project timelines, Quality issues, Resource management, SOW (scope of work) / budget.

Provide data management expertise and data management process improvement to CDM management.

Mentor other team members in training and developing data management expertise.

Manage comprehensive quality control procedures.

Knowledge / Skills / Abilities:

Participates in internal/sponsor meetings and training programs, as required, working directly with the assigned project manager to provide data management support

Manages project resources according to budget and notifies project manager and supervisor of any potential out-of-scope requests from clients

Must have experience with DM start up, maintenance and closeout activities in both paper and EDC studies

Experience in moderate to complex projects, paper based and EDC Databases. Some global project experience preferred

Requires excellent oral and written communication skills to interact with investigative sites, sponsors and vendors and to build rapport with each