At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It's only through our people that we can continue to innovate technology that will shape the future of clinical trials.

We are investing resources to create an environment our people are proud to be a part of. We want people who know their efforts are valued. This in turn leads to fantastic customer service and allows us to transform patients' lives.

Primary Responsibilities

Ensures clinical trial databases meet project requirements by:

• Creating and updating study data management documentation as appropriate, including Data Management Plan, data review plan, system configuration specifications, 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 and overseeing 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
• Understanding the requirements for study implementation and data collection
• Performing study setup, including, database structure, specifications, and obtaining and providing approvals as needed
• Collaborating with project team to develop study-specific edit check criteria
• Evaluating and implementing the standard edit checks, recommending modifications where necessary
• 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

Ensures the accuracy and consistency of clinical databases by:

• Ensuring accuracy 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
• Collaborating with appropriate project team leaders to prevent and resolve data issues

Coordination of internal and external Clinical Data Management activities and resources supporting the clinical trials data management activities by:

• Overseeing manual data review for Clinical Data Management customers
• Ensuring that study database is appropriately cleaned in accordance with agreed upon data management plan
• Independently creating the Data Management Plan, CRF Completion Guidelines, Study Specific Procedures and any Programmed Data Cleaning tools such as System Edit Checks and Listings
• Managing Data Management staff for each assigned Clinical Data Management project
• Providing management and customers with monthly project metrics and project status

Ensures client satisfaction and data integrity by:

• Taking a leadership role across all of a client's studies to ensure that their data are effectively managed.
• Assisting the management team in working with sales and marketing to promote Clinical Data Management services and expand the service offering

Mentors employees and provides project team leadership by:

• Overseeing Data Management staff to assure compliance to customer and internal requirements
• Assuring equal distribution of work across each Clinical Data Reviewer
• Assisting with conducting new hire interviews
• Training new hires on company processes and responsibilities
• Keeping management informed of issues and concerns
• 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 team to encourage growth, development and interdependence

Maintains quality service and departmental standards by:

• Adhering to Clinical Data Management processes and standards
• Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) and Work Instructions.
• Participating in the modification of company SOPs/Work Instructions related to Clinical Data Management Services

Secondary Responsibilities

Contributes to team effort by:

• Reading, understanding, and adhering to organizational standard operating procedures (SOPs)

• Assisting in establishing and enforcing departmental standards

Contribute to team effort by:

• Working with internal staff to resolve issues
• Exploring new opportunities to add value to organization and departmental processes
• Helping others to achieve results
• Performing other duties as assigned

Maintain technical and industry knowledge by:

• Attending and participating in applicable company-sponsored training

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 Skills

• Strong motivational skills and abilities, promoting a team-based approach
• Strong attention to detail skills
• Ability to work independently in a group setting; ability to adjust to changing priorities
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Strong documentation skills
• Goal-oriented
• Ability to project and maintain a professional and positive attitude

Working conditions

Travel: 0-15%

Lifting: 0-25 lbs.

Other: Computer work for long periods of time

EEO Statement

Clario is an equal opportunity employer. Bioclinica 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.