Medical Monitor or Associate Director, Oncology or Hematology

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

We see human behind every number

Medical Monitor or Associate Director, Oncology or Hematology

Location: Poland (hybrid/remote, 0,5 or 0,75 PT options)

In this role you will be responsible for medical and ethical oversight towards assigned study protocols, and for providing medical expertise to cross functional team, including support to safety cases processing, and ensuring medical integrity of the data.

Responsibilities:

• Manages projects with deliverables in the field of medical affairs
• Develops processes applicable for medical affairs (study start up from medical affairs perspective, medical monitoring principles, study close-out) and develops relevant SOPs
• Serves as a medical expert providing professional advice to prepare offers and agreements with sponsors (including information for operational department or writing elaboration)
• Provides medical support to Sales and Proposal Department: general medical study feasibility analysis, defining study execution assumptions
• Attends bid defense meetings as needed
• Identifies and defines potential risks and ethical threats, contacts opinion leaders if further expertise is needed
• Plans and coordinates feasibility process, draws up a report describing proposal of proceeding project with supposed time of recruitment, characteristic features of project, external threats, medical and ethical estimate for new projects proposals (measure - quality of descriptions, assumption and realization corresponding), approval of feasibility report
• Provides help and assistance in case of questions
• Determines criteria for centers’ selection as part of feasibility process
• Supports project managers and clinical operations project managers in trainings for project team
• Contacts opinion leaders in assigned country in order to gather required information for projects
• Develops, oversees, reviews and provides medical input to essential documents (study protocols, informed consent forms, project management plans, case report forms, safety management plan, data management plan, data review plan, monitoring plan, Developmental Safety Update Report, study reports) including final review and approval
• Provides medical support to facilitate ethics/regulatory approvals
• Provides medical coverage during study meetings (kick-off, Investigators’ Meeting, DSMB)
• Provides ongoing medical support to study team and investigators, including management of eligibility issues
• Provides medical inputs in processing of safety cases, reviews SAE / AESI reports, issues SAE queries in scope of medical consistency, assesses relatedness and expectedness of the event, drafts AOSE
• Ensures integrity of medical data (medical review) and safety signals detection
• Prepares reviews of clinical data in accordance with the Medical Monitoring Plan in cooperation with Data Management and Biostatistics Department
• Participates in blinded / unblinded data review meetings and review of clinical study report
• Analyses study reports (medical aspects)
• Participates in development review and approval of clinical development content of KCR’s internal and external promotional materials
• Supervises and verifies executions of tasks assigned to (Associate) Medical Advisors in the scope of assigned responsibilities
• Performs special projects as requested by Management in the process of development of company’s service offering
• Manages and trains personnel if assigned

Requirements:

• Medical University degree (medicine)
• Expert knowledge of oncology therapeutic area required
• Minimum of 4 years of clinical research experience
• Deep knowledge of GCP including good understanding of regulatory requirements
• Deep knowledge of clinical research processes
• Ability to work independently and efficiently
• Good planning, organization, and problem-solving abilities
• Good communication and interpersonal skills
• Good analytical and negotiation skills
• Computer competency
• Fluent in English and in local language both written and verbal
• Available for traveling (up to 25% of time), including overnight stays when necessary

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.

To demonstrate how appreciated your talent and your commitment are, KCR is offering you:

• 1 additional day off for your birthday;
• Additional days off during Christmas period;
• Referral Program;
• Country-specific benefits package;
• Onboarding process and induction training to develop deep sector knowledge and complex skills;
• Latest technology and the most advanced equipment and working tools;
• An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement;
• Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills.
  

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