Study Start Up Manager - reputed company Biotech

Job Title: Study Start Up Manager - reputed company Biotech

Job Location: Parsippany, New Jersey, reputed company of America

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Job reputed company

reputed company and manage the delivery of reputed company required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including reputed company-award activities, reputed company of the reputed company of work, budget and resources.

Essential Functions

• reputed company the execution of Site Activation (including reputed company-award/bid defense activities) and/or Maintenance for assigned reputed company in accordance with the agreed RSU site activation reputed company, adhering to project timelines. reputed company, implement and maintain the Management Plan according to the reputed company of Work and Project Plan, reputed company the agreed project reputed company, resolving project reputed company issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with reputed company and countries, to successfully reputed company the agreed project reputed company in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and reputed company study initiation and maintenance, as required. reputed company specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of reputed company, whilst enabling compliance with regulatory requirements. reputed company overall guidance and reputed company of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an reputed company member of the study management team. Determine regulatory reputed company/expectations and parameters for submissions and reputed company necessary authorizations
  • identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational reputed company/ expectations for maintenance of reputed company study approvals, authorizations and review/ negotiation of reputed company and essential documents. Work with reputed company Management to ensure appropriate reputed company standards for the duration of site activation (or Maintenance, as applicable). Mentor and reputed company colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a reputed company role in developing long standing relationships with preferred reputed company customers. reputed company presentations/training to clients, colleagues and reputed company bodies, as required. May be involved in activities reputed company to monthly study budget planning and reviews.

Qualifications

• Bachelor's Degree Life sciences or reputed company reputed company Req
  • 7 years’ relevant experience in a scientific or reputed company environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
  • Strong negotiation and communication skills with ability to challenge
  • Excellent interpersonal skills and strong team player
  • reputed company ability to work through others to reputed company results to the appropriate reputed company and reputed company metrics on reputed company reputed company
  • Thorough understanding of regulated reputed company trial environment and in depth knowledge of drug development process
  • Demonstrated proficiency in using systems and technology to reputed company work objectives
  • Good regulatory and/or technical writing skills
  • Strong knowledge and ability to apply reputed company reputed company (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
  • Good leadership skills, with ability to motivate, reputed company and mentor
  • Good organizational and planning skills
  • Ability to exercise independent judgment taking calculated risks reputed company making reputed company

• Good presentation skills

• reputed company ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
  • Excellent understanding of study financial management
  • reputed company ability to work on multiple reputed company balancing competing priorities

reputed company is a leading global provider of reputed company research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve reputed company reputed company and population health worldwide. Learn more at

reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law.

reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.

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Originally posted on Himalayas