Clinical Data Manager

Tempus Compass, LLC; Illinois; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Tempus Compass, LLC is seeking a Lead Clinical Data Manager to drive data management across clinical studies in a CRO environment. You will work with Biostatistics, Clinical Operations, and vendors to ensure data quality and regulatory compliance, particularly in oncology and early-phase trials.

The role requires extensive experience with eCRF development, data cleaning, and database locks, and offers the opportunity to shape a new data management department within a global setting.

Qualifications

• BS/BA in scientific discipline required, MS or equivalent preferred.
• 8+ years in CRO/pharma/biotech data management or related field.
• Experience with global studies and outsourced CRO models.
• Expert knowledge of data management processes and EDC design/build.
• Familiarity with CDISC SDTM and CDASH, ICH GCP, 21 CFR Part 11.

Responsibilities

• Lead data management activities for clinical studies across phases.
• Oversee eCRF development and cross-functional reviews.
• Coordinate data cuts/transfers and data reviews with vendors.
• Review CRO data management plans, CRF guidelines, and transfer specs.
• Support GCP inspection readiness and regulatory compliance.

Skills

Data management

GCP

Regulatory compliance

Vendor management

Cross-functional collaboration

CDISC SDTM/CDASH

Team leadership

Education

Bachelor's degree in scientific discipline

MS or equivalent preferred

Tools

Medidata Rave EDC

EDC data management systems

Job description

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. The Lead Clinical Data Manager will contribute and lead data management activities in support of client studies across all stages of clinical drug development. They will be responsible for working with cross functional teams leading the data management initiatives. The ideal candidate has experience working in a global CRO setting with an excellent understanding of data management best practices, good clinical practice, and applicable regulatory requirements. This candidate will have direct experience developing a data management department. Experience with all phases of clinical trials, with strong oncology and phase 1 experience, is critical.

Job Responsibilities:

• Contribute to data management activities in support of clinical studies, including: o eCRF development by leading cross-functional reviews of eCRF content.
• Database build activities, including review of edit check specifications and performance of user acceptance testing.
• Monitoring data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews.
• Oversight of database lock activities and ultimate archiving of study data.
• Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance; CROs, central and local laboratories, and other vendors.
• Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews.
• Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation.
• Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors.
• Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met.
• Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
• Support GCP inspection readiness.
• Demonstrate clear alignment with company Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence.
• Performs other duties as assigned.
• May involve travel.

Demonstration of Tempus Compass Values:

Consistently strides to demonstrate the following Highline Sciences values:

• Recognizes that the team is always stronger than the individual.
• Seeks to inspire others by demonstrating consistently strong performance.
• Treats people with respect regardless of role or point of view.
• Listens well and seek to understand before reacting.
• Provides candid, helpful, and timely feedback to colleagues.
• Demonstrates curiosity about and contributes effectively to areas outside of their specialty.
• Keeps the bigger picture in mind when making decisions.
• Never stops learning.
• Questions assumptions and offers suggestions for improvement.
• Focuses on results rather than process and seeks to minimize complexity when process is required.
• Identifies and addresses root causes, not symptoms.
• Demonstrates poise in stressful situations.
• Strives to always do the right thing.
• Questions actions that are incongruent with Highline Sciences values.

Minimum Qualifications:

• BS/BA in scientific discipline, MS or equivalent preferred, with at least 8 years related experience in a CRO/pharmaceutical/biologics/biotechnology company.
• Study/Vendor oversight experience.
• Experience with global studies, utilizing an outsourced CRO model.
• Expert knowledge of Data Management processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems.
• Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH.
• Experience working with EDC data management systems.
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11.
• Highly motivated and flexible, with excellent organizational and time management skills.
• Ability to work independently and as part of a multi-disciplinary team.
• Proficient in Microsoft Word and Excel.

Preferred Qualifications:

• Experience working with Medidata Rave EDC.
• Experience using standardized medical terminology, including MedDRA and WHODrug.
• Prior experience working for both a Sponsor company and a CRO.
• Early phase clinical trial experience

Personal Skills:

• Excellent interpersonal and communications skills (verbal and written), as well as problem solving and organization skills.
• Proven ability to work independently.
• Self-motivated, pro-active, and resourceful.
• Strong ability to manage managers and/or individual contributors.
• Outstanding organizational skills.
• Excellent analytical and problem-solving skills.
• Excellent communication skills with a diplomatic approach including the ability to work with various. personalities and perspectives.
• Excellent ability to lead cross-functional initiatives related to Data Management.
• Demonstrated proactive thought process to minimize and mitigate risk independently.
• Demonstrated ability to conduct root cause analysis cross-functionally in business problem solving and process improvement development.
• Excellent presentation skills: internal, external.

The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience.

Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Tempus was founded in August of 2015 by Eric Lefkofsky, after his wife was diagnosed with Breast Cancer. Shortly after he founded the company in an effort to bring the power of technology and artificial intelligence to cancer care, he convinced Ryan Fukushima to join as the company's first employee. Ryan and Eric began assembling a world class team, focused on building the first version of a platform capable of ingesting real time healthcare data in an effort to personalize diagnostics. We built the platform for oncology and have expanded it to neuropsychiatry, cardiology, infectious disease (through COVID), and radiology. Despite our rapid growth, our mission remains the same—to help make sure patients are on the right drug at the right time, so they can live longer and healthier lives. We're looking for people who can change the world. Who question the status quo and don't shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We're looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on.