اُرکید فارمد

منتشر شده 4 سال پیش

Job Description

Job responsibilities: • Accountable for all aspects and progress of clinical trial from study planning activities to study execution • Oversees and leads CRA team • Responsible for oversight of data management and clinical operations teams in review of clinical data • Creates, manages, measures, and reports timelines for milestone deliverables • Proactively manages potential study issues/risks and recommends solutions • Participates in the development, review, and implementation of departmental SOPs, initiatives and processes • Perform other work-related duties as assigned • Develops and maintains systems which support efficient and effective functioning of designated clinical areas Competencies: • Innovative • Problem-Solver • Communicator • Tech-Savvy • Confident Clinical Trial Manager is responsible for strategic planning in order to meet program goals, along with ensuring all reporting and study milestones are met including recruitment targets, data entry timelines, budget and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs.

Requirements

Minimum Requirements: • At least 3-year experience in a pharmaceutical company, clinical research organization (CRO) or hospital/medical environment. Preference to candidates with 1+ years’ management experience. • Being familiar to clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required • Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results • Strong attention to detail and excellent organizational skills • Strong interpersonal skills and communication skills (both written and oral) • Ability to problem solve, delegate appropriate tasks and/or mentor junior team members • Excellent sense of urgency to deliver at/surpass study conduct targets • Strong leadership skills, self-motivated, adaptable to a dynamic environment • Preference to energetic candidates with a desire to think “outside the box”. • Willingness to travel as needed, up to 20%.

Employment Type

  • Full Time

Seniority

Details

Employment type

  • Full Time

Educations

Seniority

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