Early Phase Clinical Project Manager

Syneos Health, Inc.

Canada

A distancia

CAD 90.000 - 130.000

Jornada completa

hace 42 horas
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Descripción de la vacante

Syneos Health, Inc. is seeking an Early Phase Clinical Project Manager to oversee interdisciplinary clinical studies, ensuring adherence to GCP, regulatory standards and project budgets. The role includes coordinating sponsor expectations, study conduct, and TMF integrity in a remote-capable setup with 25% travel.

You will lead cross-functional teams, manage risk, and drive on-time study delivery in collaboration with CROs and internal stakeholders.

Formación

  • Bachelor’s degree in life sciences, medicine, pharmacy, or nursing.
  • Experience in CRO environments preferred.
  • Strong knowledge of GCP/ICH guidelines and regulatory requirements.
  • Excellent communication and cross-functional collaboration skills.
  • Ability to travel approximately 25%.

Responsabilidades

  • Project Leadership and Delivery: manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, SOPs, and regulatory requirements.
  • Liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to contract.
  • Lead project team to ensure quality, timelines and budget management.
  • Accountable for financial performance and coordinating activities of study conduct partners.
  • Ensure studies are conducted in compliance with GCP and SOPs.
  • Maintain quality TMF and study information for assigned projects.
  • Prepare project management reports; develop contingency planning and risk mitigation strategies.

Conocimientos

Bachelor’s degree in life sciences
Clinical research experience
GCP/ICH knowledge
Regulatory compliance
Excellent communication

Educación

Bachelor’s degree or equivalent in life sciences

Descripción del empleo

## Early Phase Clinical Project ManagerApply: Remote (Pre-Approved): CAN-Remote: USA-Remote: Full time: Posted Today: 25114384Early Phase Clinical Project ManagerSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know:**WORK HERE MATTERS EVERYWHERE**Why Syneos Health* We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.* We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.**Job Responsibilities*** Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.* Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.* Lead project team to ensure quality, timelines and budget management.* Accountable for the financial performance of each project. Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.* Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. Accountable for all project deliverables for each project assigned.* Responsible for quality and completeness of TMF for assigned projects.* Accountable for maintenance of study information on a variety of databases and systems.* Responsible for study management components of inspection readiness for all aspects of the study conduct. Oversight for development and implementation of project plans.* Plan, coordinate and present at internal and external meetings. Prepare project management reports for clients and management.* Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.* Develops strong relationships with current clients to generate new and/or add-on business for the future.* May participate in bid defense meetings where presented as potential project manager.* May be required to line manage other project management team members and clinical monitoring staff.Qualifications:* Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.* Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements* Strong organizational skills.* Strong ability to manage time and work independently.* Direct therapeutic area expertise.* Ability to embrace new technologies.* Excellent communication, presentation, interpersonal skills, both written and spoken.* Ability to travel as necessary (approximately 25%).# We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
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