JOB TITLE:  Senior Clinical Trials Manager

GENERAL SUMMARY OF DUTIES:  This position is responsible for clinical data management of SCRI clinical trials. This includes all data management activities from protocol review to the final data deliverable to the sponsor. The Senior Clinical Trial Manager has an increase responsibility of not only supporting data management project activities according to pre-defined timelines and ensuring timely completion of those projects, but also assisting with oversight of the trial menu and the training of new employees.  This position must clearly demonstrate the ability to manage multiple projects with different sponsors and timeline demands as well as overseeing the projects and training of additional staff.

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

* Assists with the oversight of the overall trial menu

* Assists with the training of new Clinical Trials Managers and Data Coordinators

* Provides proactive and creative recommendations on how to meet goals and handle identified deviations.

* Initiates improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects

* Communicates and escalate unresolved issues at the appropriate time and to the appropriate level of management.

* Ensures all staff adheres to professional standards and SOPs established for clinical research and help with the development of new SOPs as appropriate

* Develops and executes Data Management Plans for multiple protocols simultaneously

* Collaborates with clinical project manager to determine study timelines and milestones

* Participates in project team meetings to report data management status

* Supports database design, development and testing through close collaboration with clinical programmers

* Ensures quality standards are met for patient data in clinical database through data cleaning processes and data audits

* Case Report Form/Data Clarification Form flow management and tracking

* Conducts data cleaning processes according to internal SOPs and WPGs

* Facilitates communication of data management issues to project team

* Orchestrates ongoing data entry of clinical trial data

* Maintains project documentation relevant to data management activities

* Keeps management abreast of issues and progress on all assigned projects

* Identifies and resolves any project specific data handling and data management issues

* Responsible for ensuring the integrity of data and providing recommendations for corrective action when necessary

* Mentors and coaches new and/or junior data management staff

* Contributes to internal process development and improvement

* Other duties as assigned

KNOWLEDGE, SKILLS & ABILITIES - This position requires the following minimal requirements:

* Ability to manage multiple protocols and participate on multiple project teams simultaneously

* Strong attention to detail

* Excellent communication skills, oral, written and presentation

* Excellent organizational skills

* Excellent problem solving skills

EDUCATION

Qualified candidates will have a BA/BS or equivalent experience

EXPERIENCE

2-3 years of experience with SCRI

3-5 years of Clinical Data Management experience in pharmaceutical/Biotech industry (sponsor/CRO or combination)

GCP/ICH training

CERTIFICATE/LICENSE- None