[Hiring] Medical Affairs Associate @TekWissen

Role Description

This role supports Medical Affairs activities related to expanded access programs, out-of-specification case support, and single-patient IND processes. The individual contributes to the operational execution of treatment-use and clinical support activities by:

• Coordinating study- and program-related deliverables
• Managing vendors and external partners
• Supporting site and investigator communications
• Tracking key milestones and risks
• Ensuring activities are conducted in alignment with applicable regulations, internal procedures, and program requirements

Key Responsibilities

• Assists and manages clinical trials from startup to closure; prior Clinical Operations experience is essential along with familiarity with clinical systems like CTMS, eDC, RDMS, and others.
• May assist in the review of study-related and essential start-up documents, as delegated by the study manager, including:
  • Clinical protocols
  • Informed consent forms
  • Investigator brochures
  • Pharmacy manuals
  • Monitoring plans
  • Case report forms
  • CRF completion guidelines
  • Other relevant study plans and charters
• With guidance, plays a direct role in clinical study and program execution by managing assigned components of studies or expanded access activities and serving as a member of the study team.
• Supports activities associated with out-of-specification programs, expanded access programs, and single-patient IND requests, including:
  • Coordination of timelines
  • Documentation
  • Communications
  • Cross-functional follow-up
• Manages vendors and works with multiple contract research organizations and external partners to:
  • Communicate detailed timelines
  • Oversee transferred obligations
  • Ensure performance expectations are met
  • Provide corrective instruction as needed when expectations are not met
• Attends internal team meetings and other required meetings to support program planning, issue resolution, and execution.
• Provides training, as needed, at investigator meetings and other trial- or program-specific meetings, such as site initiation visits and monthly teleconferences.
• Creates and reviews site feasibility assessments required for participation, where applicable.
• Manages and tracks key deliverables such as:
  • Screening
  • Enrollment
  • Data flow
  • Protocol deviations
  • Other program milestones
• Proactively identifies potential study or program issues and risks, recommends and implements solutions, and escalates issues appropriately to senior management.
• Prepares metrics and status updates on key deliverables for management review.
• Assists in the resolution of clinical trial queries for interim analyses, primary analyses, and final database locks, as applicable.
• Prepares site newsletters and other correspondence related to clinical trial or program conduct, including:
  • Best practices
  • Lessons learned
  • Frequently asked questions
• Assists in the resolution of routine questions from clinical trial sites and external stakeholders in adherence to:
  • ICH GCP
  • Study protocols
  • Applicable treatment-use requirements
• May participate in special projects and other duties as assigned.
• Applies standard medical and scientific terminology appropriately in support of documentation, communication, and operational execution.

Qualifications

• BS/BA/RN in nursing, science, or a health-related field with 3-5 years of related experience.

Preferred Qualifications

• Oncology/hematology experience preferred; cellular therapy experience is a plus.
• Experience with iMedidata/RAVE EDC is a plus.
• Study start-up experience from a prior site-based regulatory role, CRO role, or sponsor role is a plus.
• Ability to manage competing time demands, incomplete information, and unexpected events.
• Strong analytical and problem-solving skills.
• High attention to detail.
• Outstanding organizational skills with the ability to multitask and prioritize effectively.
• Excellent interpersonal, verbal, and written communication skills in a collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.
• Working knowledge of transplant patient care and apheresis collection is a plus.

Company Description

TekWissen® Group is an equal opportunity employer supporting workforce diversity.