The PCRP, is a Medically Qualified person with extensive experience of in a drug development/drugsafetyenvironmentormedicaldatareview. PCRPindependently or with limited guidance from Medical Director or other experienced medical staffinmedicalmonitoring,study design and regulatory agency interactions.

Job Duties and Responsibilities:

·Provides medical oversight of projects to ensure GCP/national and international regulatory requirements (as applicable), Policies/SOPs/WPs, Sponsor/Client directives, national and international guidelines are followed. Providing medical consultation to Sponsor/Client and project team for protocol development and/or project activities, as indicated.

·Maintaining availability to the site and project team including the Sponsor/Client to ensure that medical questions or medical aspects of project-related questions (e.g., safety, general protocol questions, subjects’ eligibility, inclusion/exclusion criteria, screening, randomization, unblinding, dosing, termination and discontinuation, IP specific questions, investigational product/device related questions etc.) are answered or communicated for resolution to the appropriate Sponsor/Client’s medical resource. PCRP does not instruct the site how to manage a patient from medical/clinical prospective, but advises how to understand protocol and other applicable project requirements

·Participation in development of unblinding process in close collaboration with other departments and/or functional groups

·Review laboratory results and results of study subject’s examinations

·Develop/update of the written MMP, circulating it for approval within the company and externally (with Sponsor) and maintaining MMP up-to date at all times during the project, follow it and oversee following it by other team members, escalate cases of deviations from MMP

·Oversees development and implementation of the Medical Data Review Plan, if applicable.

·Reviews project specific plans, including the Safety Management Plan (SMP).

·Develop project-related documents (e.g., clinical study protocol, clinical briefing book submitted to regulatory agencies);

·Medical input/review into project documents (e.g., protocol amendments, informed consent, clinical study report, statistical analysis plan, CSR etc.) from medical standpoint

·Develop and/or review project related documents and reports, assess and interpret project results

·Review medical literatures in the scope of preparation of project-related documents and input for preparation of the respective documents

·Review and assessment of issues related to protocol compliance incl. protocol deviation/violation, development of the corrective and preventative actions

·Advice on and participation in management of protocol deviations/violations

·Training CRAs and other team members on different topics including medical and/or safety aspects of the project or therapeutic area/indication

·Attendance to internal and external project specific meetings (e.g., Investigator meeting, Kick-off meeting, regular calls etc.);

·May provide training to other medical monitors.Attendance at data review meetings (interim analysis and final data analysis);

·May participate in dose escalation meetings for early phase studies.

·Reviews laboratory results and lab/ECG alerts, as required.

·Provides Medical review and assessment of SAEs, adverse events of special interest, SAE narratives, expedited and periodic safety reports, as requested.

·Prepares Analysis of Similar Events for expedited safety reports.Attendance at and services related to DSMB organization and management, creation of a DSMB charter, memo preparation etc.

·Provides Medical review of study data (presented e.g., in the format of listings, patient’s profiles, visual analytic templates, etc.) as per the MMP/Medical data, review plan for clarifying and resolving data inconsistencies, query management, trend assessment, etc.

·Participation in Determination of dose escalation

·Review of Medical Coding to assure medical reasonability of the codes and re-coding items if it is appropriate to ensure correct MedDRA/WHODrug coding.

·Review of the requests from Regulatory Authorities and/or Ethic Committees/IRBs and related activities (preparation of responses, participation in meeting etc.) when requested

·Ensures appropriate safety considerations have been incorporated into the Clinical Event Committee (CEC) process and ensures the applicable CEC information is included in the SMP;

·Escalates issues and notifies Line Manager, Project Manager, and/or other responsible staff if urgent safety issues are identified.

·Documenting all communication (interactions with sites, Sponsor etc.) and provides for filing in the TMF, as required

·Work closely with other functional groups and departments including but not limited to Safety/Pharmacovigilance, Project Management, Clinical Operations, Data Management, Biostatistics and QA to ensure that medical operational functions are executed effectively as per contract

·All other tasks and responsibilities allocated to the job title as defined in Policies/SOPs/WPs.

·PCRP is capable to manage projects alone.

·In case more than two Medical Monitors are assigned to the project, one MM may by Primary (Lead) MM, assuming more responsibilities e.g. communication with the Client and other functions. Details of the split of responsibilities are described in the MMP.

·Other tasks and responsibilities, as requested.

AdditionalTasksandResponsibilities(asneeded)

·Supports Business Development by preparing

·May attend professional meetings, serve as a speaker, and/or assist with Business Development efforts.

·May work with Feasibility to identify potential sites for a project; review feasibility questionnaires; and/or discuss capabilities by e-mail or phone.

Supervisory Responsibilities:

Nosupervisoryresponsibilities.

Job Requirements:

• Education
  • MD (or country-specific equivalent) required, postgraduate training/eligibility for licensure preferred.

• Experience
  • At least 8 years of total experience in both clinical practice and clinical development, at least 3 years in new drug clinical development
  • Highly desirable: PhD; Sub-investigator experience in clinical settings

• Skills/Competencies
  • Clinical thinking: ability to perform critical review and answer questions of medical nature from sites, project team (incl. Sponsor/Client) in accordance with ICH GCP guidelines, project specific documents to ensure patient safety, data integrity and successful completion of project
  • Deep understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of medical device, vaccines and drug development process
  • Positive Management: management with a calm, positive winning attitude and excellent decision-making skills
  • Effective communication: comfortable communicating both inside and outside to company.
  • Strong knowledge of the drug/device/vaccine development process
  • Extensive knowledge of GCP/applicable regulations and guidance’s, including but not limited to national/regional regulations as well as, ICH Guidance.
  • Clinical Management: able to manage clinical projects successfully and to demonstrated ability to serve as Primary (Lead) MM.
  • Time management: good sense of urgency, prioritization skills
  • Team player: effective participant as a team member and team leader
  • Creative problem-solving skills
  • ability of development and delivery of the trainings and presentations
  • Effective oral and written communication and presentation skills (at least in English) are compulsory.
  • Coach: a passion to assist others in becoming all they can be
  • Achievements: ability to define and meet requirements
  • Integrity: Understanding and acting on principles of honesty, trust and fairness

·Capabilities

• Proficient in the use of computers and Microsoft Office applications.
• Ability to work in a digital environment using computer systems
• Ability to work within a team
• Ability to work remotely
• Ability to travel, as needed