1. Conduct?medical?validation/review?tasks?directly,?or?by?coordinating?the?work?of?others.
Coordinate?related?tasks?taking?into?account?directions?from?CSD?through?medical?validation/review?plan,?other?type?of?quality?documents,?or?through?direct?communication.
Ensure?that?activities?are?conducted?in?adherence?with?quality?standard,?and?that?deliverables?are?met,?in?accordance?with?CSD?needs,?and?with?respect?to?study?timelines.
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2. In?collaboration?with?CSD?and?clinical?scientist,?and?with?their?input,?define?clear?goal?and?expectations?for?medical?validation/review?according?to?compound?safety?profile,?study?population?characteristics,?study?design?and?efficacy?criteria.
3. Communicate?regularly?on?tasks?advancement?and?completion,?difficulties?encountered,?and?potential?delays.
4. Define?timelines?for?completion?of?each?task,?in?coordination?with?team?leader,?and?CSD.
5. With?team?leader,?and?taking?into?account?CSD?perspective?on?the?task?allocated,?allocate?resources?for?the?task?and?prioritize
6. Actively?transversal?communicate?with?other?functions?(eg?TO,?GPE,?CSU,?CDOC,?TIM?and?so?on)?to?resolve?safety?data?issues?timely?and?effectively
III?–?KNOWLEDGE,?SKILL,?FORMAL?EDUCATION?&?EXPERIENCE?REQUIREMENTS?(Minimum?requirements?for?assignment?to?this?job)
A. Knowledge?And?Skills:
Medical?and?Scientific?expertise.
High?level?of?autonomy,?motivation,?good?communication?skills?as?well?as?team?player
Autonomous,?proactive,?able?to?drive?an?activity?until?final?deliverable
Self-motivated?&?results?oriented?with?attention?to?detail
Quality?focused?and?well?organized.
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B. Formal?Education?And?Experience?Required:
Medical?educational?background
Physician?with?clinical?practice?experience?in?hospitals?at?least?1?years
Prior?to?consider?previous?medical?validation/review?experience?in?Clinical?Research?and/or?Clinical?DrugDevelopment?(e.g.,?at?least?1?years?within?pharma?industry?or?CRO)
Knowledge?in?ICH,?GCP
Fluent?in?English?(spoken?and?written)
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C. Knowledge?And?Skills?Desirable?But?Not?Essential:
Technical:?knowledge?in?reporting?tools?and?technics
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