Our Culture
Any business will have its days of dealing with the unknown: factors change, people must pivot, schedules don’t always go as planned. The question of culture becomes how people working together respond and adapt in the face of change, unpredictability and even adversity.
Xentria is a group of professionals with diverse talents yet similar minds in overcoming challenges. Achievement calls for swimming with the tide of transition rather than against it. We complete projects and goals by maintaining equal parts structure and flexibility in pursuing the desired outcome for patients. We also know and embrace that progress remains closer when team members are friendly, responsive and accessible to one another.
At Xentria, we can’t promise that one day will be just like the next – but we can ensure that whatever tomorrow brings, we’ll share the challenges and triumphs alike as a team.
Diversity & Inclusion
Located in the new Lincoln Yards development in Chicago, Xentria, Inc. is a biotech company focused on solving unmet clinical needs through meaningful patient engagement and novel scientific strategy.
We promote a culture of innovation, collaboration, inclusion and compassion. At all levels of the company, we are working to advance our diversity, equity, inclusion and accessibility (DEIA) practices.
This starts with company-wide DEIA learning and education and continues with encouraging an inclusive environment. We value diverse perspectives, experience and ideas and continually review our policies and procedures to ensure fair treatment of our employees, our patients and our community.
Corporate Responsibility
We are committed to developing therapeutics that will solve unmet patient needs. We strive to do this in a sustainable way by establishing a value-based culture with a focus on our people and our community. We know that our people are our greatest assets, and we are proud to support their involvement in community initiatives and volunteering.
Equal Opportunity
Xentria, Inc. is committed to equal employment for all. In line with that commitment, Xentria provides equal employment opportunities to all employees and applicants without regard to race, color, religion, national origin, sex, age, disability and all other protections.
We strictly prohibit the harassment or discrimination of any employee or job candidate on the basis of race, color, religion, national origin, sex, age, disability or any other protected classes. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits and training. We make hiring decisions based solely on qualifications, merit and current business requirements.
Our Benefits
We strive to offer a robust benefits program that meets the needs of each of our team members.
We Offer:
competitive wages
flexible work arrangements
annual performance-bonus opportunity
short and long-term disability
extensive health offerings including medical, dental, vision
paid time off (PTO)
401(k) retirement savings with employer contribution
paid parental leave
employee wellness resources
(11) company-paid holidays
life and AD&D insurance
onsite gym membership
Each person here brings a strong sense of purpose and their own journey through clinical research into our day-to-day operations which makes for a dynamic and dedicated group.
I find purpose in working on clinical programs that work to fill an unmet need, and fostering an agile and entrepreneurial team of amazing individuals!
At Xentria, the pursuit of addressing the unmet needs of patients brings me a deep sense of purpose. I am driven by the opportunity to make a meaningful impact on the lives of patients, utilizing my skills and expertise to contribute to their well-being and the advancement of healthcare.
Upon starting at Xentria, I immediately felt a sense of belonging. The Xentria community nurtures this sense of belonging by recognizing and appreciating team members' efforts and by promoting a positive work environment. With this strong emphasis on community, my work life at Xentria is both fulfilling and rewarding.
Xentria fosters a sense of community by creating an environment where everyone feels supported and valued. This motivating environment not only drives our collective success but also makes every contribution feel significant and impactful!
The culture here is one of support and empowerment with a focus on employee life balance. Xentria values each and every employee and that is evident in all aspects of the business, from extensive benefit offerings to opportunities for both personal and professional development. Xentria truly cares about its employees as individuals and supports us in our endeavors in the office and in the community.
At Xentria, I get to work with really smart people who are experts in clinical research. I learn from them every day. But beyond the collective knowledge and creativity, I love the collaborative spirit at Xentria. Every role on the team is respected and every person is valued and encouraged to do their best work.
Job Openings
7/26/2024
Clinical Project Manager
Summary
Xentria is committed to advancing drug development through meaningful patient engagement and effective partnerships and has a track record of success in securing key collaborations in the life sciences industry. The team at Xentria is dedicated to helping early-stage products advance to the next stage of clinical development, getting them one step closer to commercial launch. Established in 2020 and headquartered in Chicago, Xentria collaborates closely with academic researchers, patient communities and biotechs as we commit to embracing the complexities of co-development projects. Our lead asset, XT MAB 16, is a monoclonal antibody, received Orphan Drug Designation by the FDA and EMA and is current in development for the rare disease of sarcoidosis.
Xentria is seeking an experienced and energetic Clinical Project Manager (CPM) to join their Clinical Operations team. This candidate will report directly to the Director, Clinical Operations and support a portfolio of early phase projects. The CPM will be responsible for overseeing all aspects of clinical trial activities on assigned studies. This will include managing outside vendors in the execution of clinical trials and development of relationships between the Sponsor and site personnel.
Essential Duties and Responsibilities
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Plans and implements clinical research studies within budget and on schedule.
- Participates in and facilitates CRO/vendor selection process for outsourced activities
- Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
- Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met
- Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
- Coordinates and leads study team meetings and update the Clinical Team on timelines and milestones for the study.
- Contributes to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
- Participates in study site selection; review and update site-specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting.
- Oversees clinical monitoring from site qualification to site closure visits and assure the integrity of clinical data with respect to accuracy, accountability, and documentation through review of case report forms, source documents, and medical records.
- Provides input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
- Reviews and negotiates contracts & budgets.
- Ensures that study documentation is maintained according to applicable regulations, industry-accepted standards, and SOPs that govern clinical studies both in the field and in-house.
- Develops SOPs, work instructions, and standardized forms to define Clinical Operations processes.
- Collaborates with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA/EMA regulations, guidelines, and principles of ICH GCP and company SOPs. Participates in the development, review and implementation of departmental SOPs and processes
Supervisory Responsibilities
No direct reports associated at this time.
Competencies
- Teamwork
- Professionalism
- Judgement
- Ethics
- Interpersonal
- Project Management
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Demonstrates advanced knowledge of and appropriate experience of relevant software packages (e.g., Microsoft Project, Word, Excel) and the company’s systems and programs.
- Experience in rare disease, orphan or neurology is highly desirable.
- Must have strong oral and written communication skills with monitoring, study management, and SOP-development experience.
- Must be highly adaptable, proactive, deadline- and detail oriented, and will maintain a high level of professional expertise through recent industry training and familiarity with clinical research publications.
- Ability to work independently under general direction in a fast paced environment
Education and / or Experience Required
Required:
- B.S. and/or M.S. degree in a scientific discipline
- At least three years of direct global clinical project management experience in the pharmaceutical or biotech setting
- Proficient to expert knowledge of GCP and EMA/FDA regulations
- Experience overseeing multiple vendors and CROs
Preferred:
- Experience with early access programs
- PMP certification or equivalent
- Experience with early phase clinical trials in OUS countries
Travel
Ability to travel up to 5% (domestic and international)
Computer Skills
- Microsoft Office
- Knowledge of SAS and database programming
- Systems integration experience
Physical Demands
While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.
Work Environment
This is a remote position.
AAP/ EEO Statement
Equal Opportunity Employer Minorities/Women/Veterans/Disabled.
7/26/2024
Director, Clinical Data Management
Summary
Xentria is committed to advancing drug development through meaningful patient engagement and effective partnerships and has a track record of success in securing key collaborations in the life sciences industry. The team at Xentria is dedicated to helping early-stage products advance to the next stage of clinical development, getting them one step closer to commercial launch. Established in 2020 and headquartered in Chicago, Xentria collaborates closely with academic researchers, patient communities and biotechs as we commit to embracing the complexities of co-development projects. Our lead asset, XT MAB 16, is a monoclonal antibody, received Orphan Drug Designation by the FDA and EMA and is current in development for the rare disease of sarcoidosis.
The Director, Clinical Data Management will take the data management lead on outsourced Phase I/II/III studies. Since the studies are outsourced, the individual will provide: vendor management oversight, review of DMPs, CRFs, DVS, perform UAT, etc. The individual must be an experienced Data Manager who is able to work independently and cross functionally. This individual must be self-motivated and collaborative amongst internal stakeholders as well as external and CRO partners as appropriate.
Essential Duties and Responsibilities
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Responsible for assessing in house data management needs and driving the selection and implementation of any in-house data management solutions including developing policies and procedures
- Responsible for clinical data management activities for outsourced studies
- Ensures data management activities for clinical trials within assigned research program(s) are completed in a timely and accurate manner
- Develops proposal requests to service providers; evaluates and approves service level agreements
- Oversees service providers to perform core data management functions including IWR/IVRS, CRF, edit check and CRF completion guidelines development, user acceptance testing, data cleaning, reviewing listings, and database locking procedures
- Works collaboratively with Biostatistics and Programming during data integration leading up to a regulatory filing
- Establish inter- and intradepartmental processes to improve the efficiency and quality of data processing
- Leads and manages DM tasks outsourced to external vendors and ensures that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory requirements.
- Develops positive partnerships with CROs and ensure a high standard of deliverables are maintained.
- Serves as the DM focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes.
- Prepares and maintains timelines for the assigned studies, and communicates to management any issues so that appropriate actions can be taken.
- Prepares status reports and updates for data management as required
- Collects and monitors study metrics.
- Attends investigators’ meetings as appropriate; gives input into the presentations that involve relevant data management topics; oversees presentations delivered by service providers
- Approves data management plans for completeness and accuracy of required documentation according to SOP.
- Oversees collection, review and archiving of the DMP and other pertinent documents for all assigned studies.
- Oversees and performs UAT on CDMS components as needed.
- Provides input into CDMS requirements, assuring protocol requirements are met.
- Supports validation efforts to minimize the company’s exposure to regulatory risk by validating all electronic data streams and systems in support of organizational objectives
Supervisory Responsibilities
No direct reports associated at this time.
Competencies
- Problem Solving
- Interpersonal
- Oral Communication
- Motivation
- Professionalism
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Strong working knowledge and prior experience directly managing/overseeing service providers and CRO’s is required
- Prior experience managing clinical data for multiple studies at one time
- Experience with computerized clinical data management systems is required
- Knowledge of SAS and database programming
- Systems integration experience
- Understanding of CDASH and CDISC standards
- Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Education and / or Experience Required
- BS Life Sciences or Computer Science
- 8-10 years of data management experience in a clinical research setting
Travel
Ability to travel up to 5% (domestic and international)
Computer Skills
- Microsoft Office
- Knowledge of SAS and database programming
- Systems integration experience
Physical Demands
While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.
Work Environment
This is a remote position.
AAP/ EEO Statement
Equal Opportunity Employer Minorities/Women/Veterans/Disabled.