Sr. Clinical Data Manager

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.