Medical Director- Oncology/Hematology (Home-Based) Bucharest

Medical Director- Oncology/Hematology (Home-Based)
Bucureşti
Bucharest, Bucharest, Romania

Job Overview

The medical department consists of a Chief Medical Officer, 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, e
CRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and
- 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 Web
Ex 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
- 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 e
CRFs 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
- 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

• Business Development Activities:

Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development

Supports business development activities with proposal development and sales presentations

Participates in feasibility discussions relating to specific project proposals

• Special Projects:

Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.

Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities

Participate in a variety of team quality improvement efforts as necessary

Perform other related duties as assigned or requested by the Chief Medical Officer

Qualifications

Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education

10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development

3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year experience

Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus

Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment

Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities

Excellent oral and written communications skills as well as interpersonal skills are essential

Oncology; Hematology;

Current or prior license to practice medicine; board certification/eligibility ideal (Preference)

Board Certified / Board Eligible: Oncology/ Hematology (Required)

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at