Clinical Trial Manager

• Bachelor’s degree in life sciences, health sciences or equivalent degree/experience; RN or pharmaceutical experience preferred but not required
• Minimum of 4 years of clinical trial management and 2+ years clinical research associate with on-site/remote clinical monitoring experience in the biotechnology/pharmaceutical/CRO industry
• Robust understanding of ICH/GCP, and knowledge of regulatory requirements.
• Working knowledge of medical terminology.
• Experience with medical laboratory testing and documentation of patient information.
• Comfortable with technology and scientific/engineering principles.

• A critical thinker and capable of problem solving and aligning the priorities with study outcomes and timelines.
• Strong clinical study/project management skills.
• Excellent communication, written and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team-building skills.
• Ability to motivate and collaborated with teams at other functional departments.
• Ability to work independently, take initiative, and meet company goals within timelines and budget.
• Able to work in a fast-paced environment with multiple competing tasks and demands, across time-zones.
• Must have a sense of urgency about problem-solving and completing projects.
• Ability to communicate with vendors and keep a high quality of clinical study
• Strong knowledge of FDA regulations and GCP.
• Proficient in Microsoft Office (excel, word, outlook, power point), electronic data capture (EDC) software (Medrio, Medidata) and other platform related to electronic Trial Master File (eTMF), CTMS and safety report

• Travel estimate 10-30% .
• Operate within standard guidelines, but must engage in some independent decision-making.
• Errors that are not quickly detected and rectified could have a significantly adverse effect on the quality of the study.
• Works closely with other Clinical Research staff, as well as staff from other departments.

• Experience with clinical studies involving organ transplantation.

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide.

We believe in taking great care of our people, so they take even greater care of our patients.

Our competitive Total Rewards package for US Employees includes:

• Competitive base salary and incentive compensation
• Health and welfare benefits, including a gym reimbursement program
• 401(k) savings plan match

• Pre-tax commuter benefits
• And more!
• Please refer to our page to view detailed benefits at https://caredx.com/company/careers

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team.

Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer-vets/disabled, and participates in the E-Verify program.

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The U.S.

EEO posters are available here .

Note: We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.

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This is the anticipated base salary range in the United States.

The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc.

Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units.

CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.