I am Garfield from Collab Infotech and I'm reaching out to you regarding an immediate position for "Clinical Data Analyst Lead" with our Leading pharmaceutical client.
Below is the job description with more details about the position. If you are interested then please send me your most updated resume by reply email or call me at 609-318-3335 and I will be more than happy to discuss this opportunity further with you.
Title: Clinical Data Analyst Lead
Location: Warsaw, IN/ Remote
Duration: 1+ Year Contract
Responsibilities include coordination of timelines and resources required to implement and maintain a variety of clinical systems as well as provide oversight and coordination of all aspects of the development and management of clinical study databases across a variety of platforms. Coordination of activities will require the development of strong, productive relationships with colleagues across the MD sector. This individual performs with little to no supervision.
Position Duties & Responsibilities:
- Collaborate with Data Management leadership (including Programming and Biostatistics) to define and document data and process standards;
- Provide in-house project support for creation, routing and approval of all system deliverables associated with clinical systems;
- Support the development and maintenance of global harmonized processes and procedures for system support;
- Support vendor evaluation, selection, contracting, and oversight activities for outsourced systems; Assist with vendor evaluation and selection activities for clinical systems;
- Work with BSDM partners, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines and milestones for study-specific systems set-up, UAT, maintenance and closeout as required;
- Lead project management activity related to the deployment of Interactive Voice/Web Response Systems (IxRS), Electronic Data Capture (EDC) Systems, CTMS, eTMF and other relevant platforms (as assigned);
- Create, review and facilitate approval of system deliverables and facilitate appropriate quality review where applicable;
- Mentor peers through review of deliverables to minimize delays during the quality review process;
- Interface between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools;
- Facilitate support requests associated with clinical systems (as needed);
- Serve as first line of contact from study initiation through go live for each clinical study. Systems may include: CTMS, eTMF, IxRS, EDCs;
- Facilitate the development of training materials and programs related to system set-up, UAT and ongoing maintenance as well as other relevant processes;
- Represent the Medical Devices Sector on Enterprise or cross-sector Clinical System teams (as needed);
- Assist with the implementation of study metrics;
- Analyzes complex change requests to determine feasibility for incorporation within clinical studies;
- Evaluates vendor supplied release documentation for implementation feasibility and collaborate with appropriate partners to define project parameters;
Functional and Technical Competencies:
- Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required;
- Previous experience in Clinical Operationspreferred;
- Demonstrated ability to manage a project in a team environment to deliver critical milestones;
- Strong proficiency in more than one Clinical system. Advanced certification preferred;
- Experience with CDISC STDM preferred;
- Excellent verbal and written communication skills;
- Knowledge of GCP and SDLC;
Education & Experience Requirements:
- A Bachelor's degree (or equivalent) in Statistics , Computer Science or related discipline (required), with at least 6 years of system support in clinical research within Medical Device or Pharmaceuticals.
- Experience in Integrations like IWRS, Balance, Safety Gateway etc?? One should have experience in integrations specially IWRS.
- Custom function programming?? It is good to have this experience for a Rave Study Builder
- Migrations ? Must have a solid migration experience for doing post production changes
- Form, folders, edit checks, matrices ? Must have an experience of building forms, folders, edit checks, matrices and data dictionaries.