Medical Officer, Oncology

  • Location

    Spain

  • Sector:

    Life Sciences

  • Job type:

    Blijvend

  • Salary:

    excellent benefits package

  • Contact:

    Vladyslav Babych

  • Contact email:

    Vladyslav.Babych@volt.eu.com

  • Job ref:

    75390-PHARM-VLB_1571847211

  • Published:

    1 jaar geleden

  • Expiry date:

    2019-11-22

  • Startdate:

    asap

In role your will be exposed to following tasks and responsibilities within range of Oncology and Onco-Immunology development projects.

  • Setting up, documenting and communicating project specific medical monitoring requirements for assigned projects.

  • Supporting medical monitors under medical guidance in the conduct of studies

  • Developing and reviewing medical monitoring and other study related plans

  • Training project team and sites in the protocols

  • Reviewing site and project team queries

  • Reviewing medical data including labs, patient profiles, CRF data and eligibility/enrollment reviews

  • Assisting Medical Monitors in business development

  • Performs scientific research for and provides input into the RFP

  • Conducting medical data review and generates data queries

  • Ensuring compliance with and adherence to all internationally recognized standards

  • Initiating medical monitoring activities during the start-up of clinical trials including development of process documents aligned with the study protocol, budget, standard operating procedures, and ethical requirements

  • Reviewing budget and scope of medical team's responsibilities addressing inadequacies or concerns with the Medical Director and/or project management team

  • Tracking study progress, proactively resolves issues, and proposing corrective action to project team/clients

  • Processing and addressing protocol non-compliances at Investigative sites and ensuring adherence to ethical guidelines

  • Collaborating with Medical Directors on the medical-operational aspects of complex clinical studies

  • Attending Investigator Meetings and interacting with Investigative site staff and client representatives

  • Is a point of contact and knowledge resource for Medical Directors to consult with on study-specific drug/device medical activities

  • Preparing for audits and inspections by sponsors or regulatory agencies

  • Reviewing and QCing documents and work of other associates, as needed

  • Mentoring other more junior members of the team

  • Supporting PV activities as needed

  • You'll need this to be considered:

  • Graduate in medicine

  • Ideally, previous clinical practice experience in oncology, (Board certification or equivalent not required).

  • CRO experience is preferred

  • Knowledge of ICH / GCP regulations

  • Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures

  • Fluent verbal and written English as well as the local language(s)

  • Excellent team player, collaborative and able to build an effective team

  • Ability to multi-task and work effectively in a fast-paced environment with changing priorities.

  • Excellent organizational and time-management skills, able to prioritize workload to meet deadlines

  • Is customer service focused in approach to work both internally and externally

  • Maintains a positive, results orientated work environment