Project Director
Veristat
Barcelona, Spain
hace 5 días

Description

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process.

We have done so by hiring talented people who align to ourand share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here.

At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.

We do things differently than large CROs and would love to have you join our Veristat team!

Key Purpose :

The Project Director provides oversight of the management and delivery of complex and high-profile clinical trial programs, including timeline, budget, and quality management of the conduct of assigned studies.

The Project Director manages projects of full-scope, regional, and global programs and is responsible for the successful planning, implementation, and execution of contracted activities.

They assure the accurate transfer of contracts from proposal through project completion, as well as clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures.

Internally, the Project Director interfaces with clinical monitoring, site management, clinical data management, SAS programming, biostatistics, pharmacovigilance, regulatory affairs, medical writing, and finance.

They also interface internally with business development, QA & compliance, and company leadership, and externally with sponsors and vendors.

Primary Duties + Responsibility :

  • Responsible and accountable for the oversight and successful execution of clinical trial programs assigned.
  • Manage overall project performance within the approved budgets and timelines.
  • Proactively recognize any change in scope and work collaboratively with contracts and Business Development to develop and ensure timely completion of change orders.
  • Implement project level governance and report on overall performance metrics.
  • Develop detailed project plans and timelines and prioritize the tasks to achieve project goals.
  • Leverage resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.
  • Responsible for overseeing production and ensuring the quality and timeliness of project deliverables.
  • Responsible for effective communication within the project team and with functional management.
  • Provide regular updates regarding the status and progress of the project to management, internal teams, and clients.
  • Act as the key client contact on assigned projects and develop successful working relationships with client to help secure repeat business.
  • Participate in and ensure appropriate qualified vendor selection, and manage vendor activities.
  • Responsible for the identification of project risks and the development and implementation of effective risk mitigation strategy.
  • Represent the clinical project team at investigator meetings and support meeting coordination.
  • Responsible for ensuring the project is inspection ready across contracted services.
  • Demonstrate thorough knowledge of, the application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
  • Participate in Business Development activities as requested.
  • Collaborate with sponsors and internal team(s) to align goals / deliverables, identify needs, develop and maintain a sustainable project management environment, ensuring consistency, efficiencies, and quality project execution.
  • Strive to consistently uphold Veristat core values.
  • Experience & Minimum Requirements :

  • Bachelor’s degree in life / health sciences or related discipline, or equivalent required.
  • 8 years of relevant clinical research experience in a Clinical Research Organization / Pharmaceutical Company, with a minimum of 6 years of Project Management experience in a CRO or pharmaceutical company required.
  • Other professional and / or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.

  • Familiarity with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research required.
  • Excellent clinical trial project management, written and oral communication, organizational, and interpersonal skills are required.
  • Proficiency in English(written and verbal) required.
  • Action-oriented and resilient in a fast-paced environment, with the ability to build and lead effective project teams, motivate others, delegate, and make and implement decisions required.
  • Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members required.
  • Ability to mentor and delegate required.
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