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Associate Project Manager


Biotechnologie et Pharmaceutique

242 jours | New York, New York, United States | Premier Research

Associate Project Manager

242 jours | New York, New York, United States | Premier Research

Premier Research

Date de début :février 21

Appliquer avant :mars 25 2021

Industrie : Santé, Biotechnologie et Pharmaceutique,

Description du poste


Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.

We’re looking for a talented and energetic Associate Project Manager to join our dynamic Team!

Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority.

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

As the Associate Project Manager, you’ll have the opportunity to advance your career and expertise by sharing responsibility with the Project Manager or Project Director for overall delivery and milestone achievement of full service projects, ensuring successful cross functional management and oversight of the project team, including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety. You also may have the opportunity to be solely responsible for projects which are limited in size or scope. In this role, you will also manage the customer-focused relationship from study award through closure by achieving on-time, on-budget, high quality results throughout the life-cycle of the project.

What You’ll Be Doing

  • Act as the liaison between Premier Research and the customer for their study or specific portion of the study.
  • Develop project plans for all phases of the project lifecycle, including quality, risk management and proactive contingency plans, ensuring that issue escalation and resolution is clear; monitor the quality of project deliverables and addresses quality issues with the appropriate team members
  • Chair project team meetings or teleconferences
  • Manage the project team to ensure study is progressing in accordance with client and Premier Research requirements; facilitate communication across the project team and departments; maintain and evaluate study progress, using company tracking systems, project timelines, and budget reviews; provides project progress reports including team performance against contract, customer expectations, and project baselines
  • Facilitate team training in accordance with protocol or project requirements, including therapeutic, protocol specific, and process training
  • Support resolution of project related conflicts with necessary corrective action and alert senior management to potential issues
  • Continually review and make recommendations to ensure adequate resources are available to meet project deliverables and milestones
  • Oversee project documentation, ensuring Trial Master Files are completed by the functional groups and audit ready; supports study audits and responds to audit reports

You'll Need This Background To Be Considered

  • Undergraduate degree in a clinical, biological, scientific, or health-related field along with 4 years relevant experience in a pharmaceutical company/medical device company/CRO including trial management support or equivalent or a combination of experience and education
  • Budget/finance experience on a project level
  • Good therapeutic and protocol knowledge
  • Knowledge of ICH/GCP regulations as well as working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
  • Is customer service focused in approach to work, both internally and externally with strong verbal and written communication skills; approaches challenges creatively
  • Highly confident and effective presenter with knowledge of web-based communication tools; excellent verbal and written communication skills with a customer-service focus
  • Maintain a positive working environment that embodies a culture of aspiration, caring, empowerment and a #oneteam approach with the ability to build an effective team; excellent team player who encompasses the management skills to motivate, enthuse and lead teams; accountable, dependable and strong commitment
  • Excelled organizational and time-management skills with the ability to multitask, meet deadlines and work effectively in a fast-paced environment with competing priorities
  • Self-starter with common sense and able to act on own initiative
  • Ability to apply clear and consistent performance standards as well as identify concerns and resolve decisively and objectively

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