Clario. The Best of ERT & Bioclinica
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 Assist with project support and administration for projects utilizing Clario RTSM technology by: Understanding and effectively utilizing the primary RTSM system version used by the client.
Utilizing other RTSM support tools to manage and maintain on-going clinical studies.
Supporting multiple studies and customers in various stages of the study lifecycle.
Working closely with the RTSM Leads (study maintenance managers) on assigned study support tasks to meet project/task timelines.
Keeping RTSM Lead (maintenance manager) advised of task status and escalating as appropriate.
Serving as additional point of contact to sponsors, sponsor vendors, sites, etc.
Resolving or escalating study support issues in accordance with all documented processes, work instructions or standard operating procedures.
Attending and participating in required sponsor or study maintenance meetings.
Coordinating, hosting, or recording minutes for internal and external meetings.
Creating, updating and maintaining study specific documents, including but not limited to, study specific project plans, user guides, and data and parameter change plans into a single version-controlled source.
Maintaining study specific binder with current versions of study maintenance documents.
Collecting, documenting, and performing customer requested parameter and data changes in alignment with documented processes.
Facilitating translations of RTSM system and associated documentation.
Working exclusively with Unblinding (confidential) data and information.
Protecting blinded information at all times during both verbal and written communication.
Creating and maintaining metrics as needed.
Responding to tasks from the Solutions Engineer (study implementation manager) for study changes and upgrades.
Keeping manager advised of current issues.
Providing urgent study specific support after business hours as needed.
Contributes to overall department communication, cooperation and efficiency by: Suggesting improvements to work processes that enhance the quality of team/client support and improve efficiency.
Creating, implementing and presenting training materials and tools for both internal and external teams.
Preparing for and participating in internal/external audits and investigations.
Participating in the creation of audit response documentation as part of Quality Investigations.
Continuously improving understanding of business and client processes.
Secondary Responsibilities Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”) Assisting in establishing and enforcing departmental standards Contributes 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 Maintains Technical and Industry Knowledge by Attending and participating in applicable company-sponsored training Qualifications: Education: Bachelor’s degree preferred Experience: Experience managing project timelines is preferred 2 years of experience in customer facing engagements 2 years utilizing Microsoft Office Suite or similar tools Working with clinical trials and/or within pharmaceutical environment preferred Experience with interactive response technologies, drug supply, randomization strategies, or other clinical trials management methods preferred Experience working within regulatory guidelines such as ICH, FDA, EMEA preferred Additional skill set: Conduct reflects integrity, honesty, and responsibility for decisions and behavior Able to handle difficult and stressful situations with professionalism, initiative, logic and good judgment Able to apply procedures across an extensive range of scenarios requiring strong problem solving and investigation skills Demonstrated ability to manage time and multiple tasks, effectively prioritize responsibilities, and successfully meet deadlines Ability to work independently and in group settings, leveraging relationships for the completion of common goals Excellent attention to detail and orientation toward meticulous, well organized work Strong interpersonal and communication skills, both verbal and written Goal oriented Working conditions: Travel: 5-20% 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.