Schrödinger is seeking a highly competent and driven Senior Manager, Clinical Data Management to join our Early Clinical Development Team on a six-month contract. This role will report directly to the Sr. Director, Clinical Data Solutions and Sciences and will be crucial in conducting various activities necessary for steering and managing the clinical data aspects of first-in-human and proof-of-concept drug development trials.
As a Manager of Clinical Data Management at Schrödinger, your duties will include supervising and managing the clinical trial data processes to guarantee the quality, accuracy, and integrity of clinical data across our research programs. You will collaborate closely with cross-functional teams and external partners to ensure successful execution of clinical trials.
Our Early Clinical Development team is at the cutting edge of drug development, managing clinical proof of concept through a proprietary physics-based drug design and optimization platform. This environment is fast-paced, dynamic and provides an exciting opportunity for impactful contributions.
Who will love this job:
- An experienced, self-motivated clinical data manager who enjoys performing the everyday tasks of clinical data management.
- A team player who is goal-oriented and has strong leadership skills to supervise the clinical data team including CRO and vendor partners to meet clinical data timelines and deliverables.
- A clinical research expert who can interpret complex clinical trial protocols, identify the clinical data necessary for study analysis, and align this to relevant clinical data standards (e.g., CDISC, CDASH).
- An experienced clinical data manager with expert knowledge in identifying, setting up, testing, and managing various electronic data capture systems.
- An excellent communicator who thrives within a dynamic, growth-oriented, entrepreneurial environment.
What you will do:
- Execute on agreed short-, mid-, and long-term clinical data goals to ensure deliverables are met in a timely, cost-effective manner and of high quality.
- Collaborate with internal and external cross-functional teams to define, test, and implement data systems to fulfil the necessary clinical data needs (e.g., EDC, IRT, ECG, ePRO) for the study.
- Oversee the development of data management documents for clinical trials and orchestrate data transfer plans for external data.
- Manage data transfers by executing data transfer agreements, setting up validated automated data flows at the study level, and managing data receipt through archival.
What you should have:
- Bachelor’s or advanced degree in Life Sciences/Clinical Research.
- At least twelve (10+) years of clinical data management experience within both pharmaceutical and biotech environments, as well as early clinical development oncology.
- Experience leading global first-in-human and proof-of-concept oncology clinical trials.
- Extensive critical thinking skills.
- Strong knowledge of clinical trial data standards (CDISC/SDTM/Adam).
- Excellent leadership and team management skills.
- Strong communication and interpersonal skills.
- Knowledge of regulatory guidelines (FDA, EMA, ICH) relating to clinical data management.
Estimated annual base salary range: $140,000-$180,000 (NY only). Actual compensation package will depend on several factors, such as experience, education, held degrees, market data, and business needs.
Pay and perks:
Schrödinger understands that our people make the company exceptional. Hence, we offer a competitive salary, stock options, and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, flexible work schedule, and a parental leave program. We offer regular catered meals in the office, a relaxed but engaged company culture, and over a month of paid vacation time.
We believe diversity not only makes a better business but also an innovative one. We commit to ensuring our staff, representing a range of viewpoints and backgrounds, can contribute and grow in a safe environment.
Sound exciting? Apply today and join us!