Our client, a world leader in biotechnology and life sciences, is
looking for a “Medical Affairs Associate (100% Remote)”.
Job Duration: Long Term Contract (Possibility of Extension)
Pay Rate: $36.70/hr on W2
Company Benefits: Medical, Paid Sick leave(as
per state policy)
Seeking a Medical Affairs Associate to support clinical operations and
Medical Affairs programs, including Expanded Access Programs,
Out-of-Specification (OOS) case support, and Single-Patient IND requests. This
role will coordinate study activities, vendors, clinical sites, documentation,
timelines, and cross-functional deliverables while ensuring compliance with
applicable regulations and procedures.
Key Responsibilities
- Support clinical
trials from study start-up through closeout.
- Coordinate
Expanded Access Programs, OOS cases, and Single-Patient IND activities.
- Review and
maintain essential clinical study documents, including protocols, ICFs,
IBs, and CRFs.
- Coordinate CROs,
vendors, investigators, and clinical trial sites.
- Track enrollment,
screening, data flow, protocol deviations, milestones, and study
deliverables.
- Support site
feasibility, investigator meetings, site communications, and training.
- Monitor program
risks, resolve operational issues, and escalate concerns.
- Prepare study
metrics, status reports, newsletters, and management updates.
- Support clinical
data queries and database lock activities.
Required Qualifications
- Bachelor's degree
in Nursing, Life Sciences, or a related healthcare field.
- 3–5 years of
Clinical Operations / Clinical Trial experience.
- Familiarity with
CTMS, EDC, and clinical trial documentation.
- Strong
organizational, communication, and problem-solving skills.
- Ability to manage
multiple priorities in a fast-paced environment.
Preferred Qualifications
- Oncology or
Hematology clinical trial experience.
- Cellular therapy
experience.
- iMedidata / RAVE
EDC experience.
- Study start-up
experience in a CRO, sponsor, or site-based regulatory environment.
- Exposure to
transplant patient care or apheresis collection.
If interested, please send us your updated resume at
hr@dawarconsulting.com
/
akansha@dawarconsulting.com