Prelude Therapeutics Incorporated
Salary $71,109 - $222,934 a year job type full-time number of hires for this role 1
Clinical data management: 10 years (required)
Full job description
Prelude is an early-stage biotechnology company founded by proven scientists in cancer drug developmentOur research is focused on developing highly selective and differentiated small molecule therapeutic agents targeting novel pathways for the treatment of cancer and rare diseases.
Prelude offers a vibrant and collegial work environment and excellent career growth opportunitiesPrelude is ideally located within 25 minutes from the philadelphia international airport at the delaware innovation space, an emerging research campus in the dupont experimental station.
The associate director/director, data management will be responsible for providing data management leadership and day-to-day data management for assigned prelude therapeutics’ programs.
Responsibilities and duties:
· oversee various third-party data management providers (edc and data management service vendors) for prelude’s clinical programs.
· implement internal prelude data management standards (including edc and cdisc), external data transfer and acceptance specifications, and documentation processes for prelude clinical data (based on the agreed clinical standards)If needed, develops new standards in close collaboration with stats programming.
· perform internal data management activities for prelude’s clinical programs including but not limited to edc uat, manual data reviews (patient profiles, line listings), laboratory sample reconciliation, external data transfer review, sae reconciliation, quality checks, if applicable.
· ensure on time edc development, data entry, data quality, data integrity, and data accuracy and regulatory compliance for prelude clinical programs.
· act as a liaison between medical, clinical science, clinical operations, biostatistics, pharmacovigilance, medical, prelude leadership and third-party vendors for data management matters.
· partner with the clinical development team to assist with the development of risk based monitoring strategies.
· drive timely execution of responsible clinical data programs to achieve poc (go/no-go
· manage data management related contracts, change orders, invoicing, and work being performed to contract.
· obtain prelude’s yearly licenses to meddra and whodrug.
· assist with the long-term strategic data planning including adherence to data timelines.
· partner with qa and other functions to develop and maintain data management specific sops, work instructions and processes.
· develop, manage, and mentor prelude data management personnel.
· maintain external network to ensure industry best data practices are implemented for prelude clinical programs.
· bs (required), ms/mba degree (preferred).
· 10+ years (associate director), 12+ years (director) of related industry data management experience with at least 4 years of oncology experience.
· a minimum 2 years vendor management experience including vendor contract oversight.
· sop, work instruction and data management process development experience
· prior data management (supervisory), mentoring or task delegation experience.
· ability to think critically and strategically with a long-term goal always in mind.
· capable of building and guiding complex diverse teams composed of direct reports, and partners both internal and external.
· capable of creative problem solving and risk mitigation.
· scientifically focused with an ability to communicate with research scientists and physicians.
· excellent written and oral communication skills.
· highest level of personal integrity and work ethics.
· ability to adapt to changing priorities whether corporate or clinical program related.
Walking, feeling, talking, hearing and repetitive motion.
Sedentary workInvolves sitting most of the time; exerts up to 10 pounds of force occasionally to lift, carry, push, pull or otherwise move objects, including the human body.
Visual acuity requirements:
The worker is required to have close visual acuity.
NoneThe worker is not substantially exposed to adverse environmental conditions.
Prelude therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local lawsThis policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Prelude therapeutics, incDoes not accept unsolicited resumes from recruiters, employment agencies, or staffing firmsTo conduct business with prelude, a master services agreement (msa) must be executed and confirmed prior to submitting any information relating to a potential candidateWithout a signed msa, prelude shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.
And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed msa, prelude has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.
Job type: full-time
Pay: $71,109.00 - $222,934.00 per year
Employee assistance program
Flexible spending account
Health savings account
Paid time off
8 hour shift
Do you have experience managing clinical 3rd party vendors?
Have you been involved in reviewing or developing clinical data standards?
Clinical data management: 10 years (required)
Only full-time employees eligible
Remote interview process
Personal protective equipment provided or required
Plastic shield at work stations
Social distancing guidelines in place
Sanitizing, disinfecting, or cleaning procedures in place