Medical Director - Oncology , Sponsor Dedicated (12 Months Fixed Term Contract)

IQVIA; Madrid; Vor Ort; EUR 120.000 - 170.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Medical Director to provide medical and scientific oversight for clinical research programs, study teams and investigators.

The Medical Director serves as the primary sponsor medical contact and ensures protocol integrity, safety monitoring, and compliance with GCP. You will lead medical monitoring activities, train teams, and provide on-call support for protocol questions and safety issues.

Qualifikationen

• MD/DO or equivalent with clinical trial experience.
• Strong knowledge of GCP and regulatory requirements.
• Ability to lead cross-functional teams and interact with sponsor medical teams.

Aufgaben

• Provides medical and scientific input to clinical research programs, including review of protocols, safety data, and regulatory submissions.
• Ensures medical activities run according to GCP and regulatory standards.
• Establishes and maintains a network of medical/scientific consultants and oversees Medical Director activities.
• Interacts with clients regarding drug development programs, study design and protocol.
• Reviews protocols for clinical, safety, and efficacy variables and provides training on protocol/therapeutic areas.
• Provides on-call coverage for protocol queries and site support and serves as primary contact for sponsor medical teams.

Kenntnisse

Medical oversight

Clinical trials

GCP compliance

Team leadership

Sponsor liaison

Ausbildung

MD or DO or PhD in life sciences

Jobbeschreibung

Job Overview

The medical department consists of a Chief Medical Officer, Medical Directors, Sr Medical Directors, Medical Writers, and Safety Associates. The Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Medical Director also provides review, advice, and leadership for potentially or awarded clinical research programs. The Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below:

Essential Functions

Functions as project team member:

• Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation, and reporting.
• Ensures medical activities run according to GCP and operate with highest efficiency.
• Establishes and maintains a network of medical/scientific consultants, etc.
• Supervises and manages Medical Director activities.

Clinical Activities:

• Interacts with clients regarding drug development programs, study design and protocol.
• Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints.
• Interacts in team approach to develop statistical and data management sections of the protocol.
• Reviews the final protocol for clinical, safety and efficacy variables.
• Provides project team training on protocol and/or therapeutic areas.
• Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.
• Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators, and site staff and/or participation in teleconference and WebEx presentations.
• Presents protocol and/or safety reporting information at investigator meetings.
• Develops project medical monitoring plans as requested.
• Provides on call coverage for protocol queries and site support.
• Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.

Safety Monitoring and SAE Reporting Activities:

• Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study.
• Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed.
• Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data.
• In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind).
• Interact with appropriate FDA officials concerning safety and other study related issues, as requested.

Data Activities:

• Provides medical review of eCRFs for clinical accuracy.
• Provides medical review of data analysis plan.
• Reviews safety fields at case freeze for reconciliation (if needed).
• Works with data group to reconcile SAE events as needed.
• Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends.
• Reviews data tables, listings, and figures.
• Reviews and/or writes portions of final clinical study report.

DSMB/Adjudication Committee Activities:

• May assist sponsor in choosing committee members.
• May serve as a non-voting member to convene and organize proceedings.
• May develop operating guidelines in conjunction with committee members and submits these to sponsor for review.
• May determine data flow with sponsor to ensure reporting accuracy.
• Can ensure DSMB feedback is given to sites for IRBs.
• All DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor.