Reference #: R13929
The Sr. CDM provides data management expertise and oversight for studies in specific modalities or systems within a therapeutic area. Attends Kick Off Meetings along with the study CDM and CDM Manager. Reviews and approves study documents, and provides training. Allocates studies in consultation with the CDM Manager. Handles escalations in consultation with the CDM Manager.

Primary Responsibilities

Ensures clinical trial databases meet project requirements by:
Creating and updating study data management documentation as appropriate, including system configuration specifications, data validation plans, external data reconciliation specifications, and data transfer specifications
Collaborating with appropriate project teams as needed to stay abreast of any changes that could affect data collection, cleaning and/or transfers
Executing or overseeing Transmittal Form creation and all data management documentation and deliverables for assigned studies
Participating in Kick Off Meetings (KOMs) for assigned studies
Attending and participating in study team meetings
Participating in sponsor meetings as requested
Reviewing documentation and requirements for new projects and anticipating impact to data management and therapeutic area standards/processes
Participating in KOMs for studies in group

Works with senior level staff to ensure data management deliverables are properly executed by:
Understanding the requirements for study implementation and data collection
Performing study setup, including TF design, database structure, specifications, and obtaining and providing approvals as needed
Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources
Collaborating with the project team to proactively identify and address issues and develop study-specific procedures as needed
Collaborating with project team to develop study-specific edit check criteria
Maintaining organized, complete, and up-to-date study documentation
Reviewing and approving study setup specifications and documentation
Developing and tracking timelines and ensuring CDM project milestones are met in coordination with the project team
Evaluating and implementing the standard edit checks, recommending modifications where necessary

Ensures the accuracy and consistency of clinical databases by:
Performing or coordinating validation of data capture configurations, Missing vs. Expected reports, and data transfer programs
Ensuring accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines
Reviewing data and identifying errors/inconsistencies
Preparing and validating ad hoc data listings as necessary
Tracking outstanding issues and following-up until resolution
Ensuring that system bugs and needed enhancements are reported to CDM Management and the applicable Engineering Product Manager, and that any stop-gap CDM programming is approved
Collaborating with appropriate project team leaders to prevent and resolve data issues
Mentors team members, if applicable, by
Training team member on departmental processes and documentation methods
Assisting team member with problem solving and troubleshooting issues
Leading by example with professional and collaborative conduct
Answering questions and proposing technical solutions specific to data management processes
Delegating appropriate and challenging assignments to CDAs and CDMs to encourage growth, development and interdependence

Performs supervisory functions by:
Coordinating and conducting new hire interviews; facilitating hiring decision
Managing training of new hires on departmental processes and responsibilities

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by:
Adhering to department processes and standards
Reading, understanding and adhering to applicable Standard Operating Procedures (SOPs)
Assisting in establishing and enforcing departmental standards
Working with CDM management to discuss and seek resolution to department issues

Contributes to team effort by:
Working with internal staff to resolve issues
Exploring new opportunities to add value to the organization
Helping others to achieve results
Performing other duties as assigned
Participating in assigned departmental initiatives
Participating in training and coaching new hires on departmental processes and tasks
Participating in designing and creating new tools to help improve the department processes

Maintains Technical and Industry Knowledge by:
Attending and participating in applicable company-sponsored training
Reviewing literature to stay current in the Data Management field

Qualifications:

Education:
Bachelor's degree in Computer Science, Life Sciences or related field preferred, or equivalent experience required
Experience:
4+ years experience in comparable position within the pharmaceutical, biotech or CRO industry required
Experience working with office productivity tools including Word, Excel and Access preferred
Proven ability in problem solving
Working knowledge of relational database organization and validation
Familiarity with SQL and SAS desirable
Knowledge of industry Clinical Data Management systems and programming languages desirable
Strong attention to detail and ability to triage and aid in resolution of escalations
Knowledge of clinical research, GCP, GCDMP, and related regulatory requirements required
Understanding of software development cycle and 21 CFR Part 11 compliance requirements required
Understanding of clinical trial terminology required
Additional skill set:
Ability to work independently in a group setting; ability to adjust to changing priorities
Excellent attention to detail
Strong interpersonal and communication skills, both verbal and written
Strong documentation and organizational skills
Ability to project and maintain a professional and positive attitude

Working conditions:
Travel: 0-15%
Lifting: 0-25lbs
Other: Computer work for long periods of time

EEO Statement
Clario is an equal opportunity employer.Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.