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Medical Affairs Associate
DAWAR CONSULTING INC. Support clinical trials from study start-up through closeout .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials from start-up to closeout, ensuring compliance with regulations and effective coordination among stakeholders. Proficient in clinical trial documentation and data management, with strong organizational and communication skills.
Highest-signal resume keywords
Clinical Trial ManagementCTMS FamiliarityEDC ExperienceOncology Clinical Trial ExperienceStudy Start-Up Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical OperationsClinical Trial DocumentationData Flow TrackingProtocol Deviation ManagementStudy Metrics PreparationDatabase Lock ActivitiesEnrollment TrackingSite Feasibility SupportOperational Issue ResolutionRegulatory Compliance
Soft Skills
Strong Organizational SkillsEffective CommunicationProblem-Solving SkillsAbility to Manage Multiple Priorities
Tools & Technologies
IMedidataRAVE EDC
Industry Keywords
Clinical TrialsExpanded Access ProgramsSingle-Patient INDCRO CoordinationTransplant Patient CareApheresis CollectionHematologyCellular Therapy
About the role
Key responsibilities & impact- 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
- Ensure compliance with applicable regulations and procedures
Requirements
What you’ll need- 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
- Oncology or Hematology clinical trial experience (preferred)
- Cellular therapy experience (preferred)
- iMedidata / RAVE EDC experience (preferred)
- Study start-up experience in a CRO, sponsor, or site-based regulatory environment (preferred)
- Exposure to transplant patient care or apheresis collection (preferred)
Benefits
Comp & perks- Medical
- Paid sick leave (as per state policy)
- Possibility of contract extension