Job Overview:
The SCRP is a Medically Qualified person without or with limited experience in a drug development/drug safety environment or medical data review. SCRP works together under supervision of Medical Director or other experienced medical staff in medical monitoring, study design, and regulatory agency interactions.
Activities provided by SCRP include advisory support of medical nature with the aim to ensure the safety and well-being of study participants, integrity of the project data in accordance with the clinical trial protocol/clinical study protocol (or equivalent documents), standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable directives and regulatory requirements. Responsibilities of SCRP include medical inputs of assigned projects (e.g., clinical trial, clinical study, Non-Interventional Study, Registry study, etc.) from both a medical and scientific perspective. SCRP provides and/or oversees medical monitoring activities, including development and/or review of project-specific Medical Monitoring Plans (MMP), Medical Data Review Plans (MDRP) and similar plans, review of other project-specific plans, responding to medically related questions, controlling medical aspects of the questions arising atanystageofaclinicaltrialandmaintainingmedicaloversightfortheconductofaclinicaltrial. The SCRP acts as liaison at study level between the Sponsor/Client responsible for final medical decisions made in a project, the investigational sites, and the project team. To perform functions, the SCRP may need to be available up to 24 hours/7 days a week as required. Scope of responsibilities of the SCRP and availability time depends on the contract with particular Sponsor, or it’s appropriately authorized designated person (Sponsor/Client). All services must be provided timely as predefined and within assigned budget (or within allocatedtime).
Job Duties and Responsibilities:
Job duties differ from project to project and are described in the contract, project-specific Plans (e.g., MMP), and/or other documents agreed with Sponsor/Client. Job duties also comprise any other tasks as defined by applicable Policies/SOPs/Work Procedures (WPs) and, in general, include but are not limited to the following:
· Medical oversight of projects to ensure applicable Policies/SOPs/WPs, Sponsor/Client directives, national and international guidelines are followed. Providing medical consultation to Sponsor/Client and project team for projectactivities
· 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, drug-specificquestions,investigationalproduct/devicerelatedquestions,etc.)areanswered or communicated for resolution to the appropriate Sponsor/Client’s medical resource. SCRP 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’sexaminations
· Develop/update the written MMP, circulating it for approval within the companyand externally (with Sponsor) and maintaining MMP up-to-date at all times during the project, following it and overseeing following it by other team members, escalating cases of deviations from MMP
· Develop project-related documents (e.g., clinical study protocol, clinical briefing book submitted to regulatoryagencies)
· 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 andinterpret projectresults
· Review medical literatures in the scope of preparation of project-related documentsand input for preparation of the respectivedocuments
· Review and assessment of issues related to protocol compliance incl.,protocol deviation/violation, development of corrective and preventativeactions
· Advice on and participation in management of protocoldeviations/violations
· Training CRAs and other team members on different topics,including medical and/or safety aspects of the project or therapeuticarea/indication
· Attendance to internal and external project-specific meetings (e.g., Investigator meeting, Kick-off meeting, regular calls,etc.)
· Attendance at data review meetings (interim analysis and final dataanalysis)
· Attendance at and services related to DSMB organization and management, creationof a DSMB charter, memo preparation,etc.
· Medical review of subject’s data (presented, e.g., in the format of listings, patient’s profile,etc.)aimingforidentificationofnon-reported AE,clearingthedata,clarifyingand resolving data inconsistencies, query management,etc.
· Participation in Determination of doseescalation
· Review of Medical Coding to ensure medical reasonability of the codes andre-coding items if it isappropriate
· Review of the requests from Regulatory Authorities and/or Ethic Committees/IRBs and related activities (preparation of responses, participation in meetings, 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
· Triggering discussion, sending out notifications, and performing associated activities related to the Risk/Benefit ratiochanges
· Provide input to frequently asked questionslog
· Maintain adequate documentation of interactions with sites, projectteam, Sponsor/Client, and other partiesinvolved
· Provide availability (to all or any: sites, Sponsor/Client, project teams) via call-in number up to 24 hours/7 days a week or other schedule as agreed by contract
· Documenting all communication (interactions with sites, Sponsor/Client, internal team members, and external parties, etc.) as required per MMP
· Work closely with other functional groups and departments, including but not limitedto Safety/Pharmacovigilance, Project Management, Clinical Operations, Data Management, Biostatistics, and QA to ensure that medical operational functions are executed effectively as percontract
· All other tasks and responsibilities allocated to the job title as defined in Policies/SOPs/WPs
· SCRP is capable to manage projectsalone
Additional Tasks and Responsibilities (as needed)
· Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) – review of documents provided to DSMB and/or DMC, support in meeting coordination, participation inmeetings
· Clinical Event Committee(CEC) –providingmedicalsupportforadjudicationprocessand participation inmeetings
· Responses to regulatory agencies and governments - assisting in preparing safety portions of theresponses
· Medical Safety Review Meeting (MSRM) – participation in themeeting
· Trainstaffandprojectteamsondifferenttopics,incl.proceduresrelatedtomedical reviewandinterpretation;trainingonspecificindicationsortherapeuticareasetc.
· Assist with and/or support the safety aspects of all relevant study documents including, but not limited to, Investigator Brochures (IB), Informed Consents, Package Labels, Core Safety Information, Protocols, Final Clinical Study Reports (CSR),etc.
· Provide review and input for SOPs and Guidelines
· Take part in meeting with existing and potential Clients, support business development activities
· Support Business Developmentbyprovidingmedicalandscientificadviceandinput,incl. preparation for and participation in Bid defenses, preparation of the Proposals and/or responses to the request for Information from Clients,etc.
· All other Tasks and Responsibilities assigned to MM in applicable SOPs
Supervisory Responsibilities:
No supervisory responsibilities.
Job Requirements:
Education
o MD with postgraduate degreerequired
Experience
o At least 7 years of total experience in both clinical practice and clinical development, at least 2 years in new drug clinicaldevelopment
o Highly desirable: Ph D; Sub-investigator experience in clinicalsettings
Skills/Competencies
o Clinical thinking: ability to perform critical review and answer questions of medical nature from sites, project team (incl. Sponsor/Client) in accordance with ICHGCPguidelines,projectspecificdocumentstoensurepatientsafety, data integrity, and successful completion ofproject
o Deep understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of medical devices, vaccines, anddrug developmentprocesses
o Positive Management: management with a calm, positive winning attitudeand excellent decision-makingskills
o Strong knowledge of the drug/device/vaccine developmentprocess
o Regulatory guidelines expertise: knowledge of international guidelines and country-specific regulatory requirements (CDE, FDA, ICH GCP,etc.)
o Clinical Management: able to manage clinical projectssuccessfully
o Time management: good sense of urgency, prioritizationskills
o Team player: effective participant as a team member and teamleader
o Creative problem-solvingskills
o Ability to clearly and efficiently communicate with site and team membersboth inside and outside to company; development and delivery of the trainings and presentations
o Achievements: ability to define and meetrequirements
o Integrity: Understanding and acting on principles of honesty, trust, andfairness
o Coach less experienced CRPs.
Capabilities
o Ability to work in a digital environment using computersystems
o Ability to work within ateam
o Ability to workremotely
o Ability to travel asneeded #LI-XX1 The company will not accept unsolicited resumes from third-party vendors.
