Project Manager II- Early Phase

2 weeks ago

Adelaide, South Australia Syneos Health - Australia Full time

Description



Project Manager II



Syneos Health is a foremost fully integrated biopharmaceutical solutions organization established to speed up customer success. We translate distinctive clinical, medical affairs, and commercial insights into outcomes to tackle modern market realities. Our Clinical Development model places the customer and the patient at the core of all our activities. We are always seeking ways to simplify and streamline our operations not only to make Syneos Health more convenient to collaborate with but also to make us more appealing to work for.


Whether you engage with us in a Functional Service Provider partnership or a Full-Service environment, you'll work alongside enthusiastic problem solvers, innovating collectively to support our customers in reaching their objectives. We are adaptable and committed to hastening the provision of therapies because we are enthusiastic about changing lives.


Discover what our 29,000 employees in 110 countries already understand:


WORK HERE IS SIGNIFICANT EVERYWHERE



Why Syneos Health

  • We are enthusiastic about developing our staff through career advancement and progress; supportive and engaged line management; technical and therapeutic area training; peer acknowledgment and comprehensive rewards program.
  • We are dedicated to our Total Self culture - where you can genuinely be yourself. Our Total Self culture unites us globally, and we are committed to looking after our staff.
  • We are recurrently constructing the company that we all desire to work for and that our customers desire to collaborate with. Why? Because by incorporating diversity of thoughts, backgrounds, cultures, and perspectives, we can establish an environment where everyone experiences a sense of belonging.

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 guarantee prompt study launch, execution, and closure in line with the Customer's and the Company's contractual agreement.
  • Lead the project team to ensure quality, timelines, and budget management.
  • Responsible 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 carried out in compliance with GCP, relevant SOP's, and regulatory requirements.
  • Accountable for all project deliverables for each assigned project.

Documentation and Reporting:

  • Responsible for the quality and completeness of TMF for assigned projects.
  • Accountable for the upkeep of study information on various databases and systems.
  • Responsible for study management facets of inspection readiness for all study conduct aspects.
  • Supervision of the development and implementation of project plans.
  • Plan, arrange, and present at internal and external meetings.
  • Prepare project management reports for clients and management.
  • Developing contingency planning and risk mitigation strategies to ensure the successful accomplishment of study goals.

Business Development:

  • Build strong relationships with current clients to generate new and/or additional business for the future.
  • May participate in bid defense meetings as a potential project manager.

Management:

  • May be required to supervise other project management team members and clinical monitoring staff.


Qualifications


What we're seeking


  • Bachelor's Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or a similar combination of education and experience.
  • Experience in a clinical research organization (CRO) and relevant therapeutic background is preferable.
  • Strong understanding of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
  • Strong organizational skills.
  • Effective time management and ability to work autonomously.
  • Direct expertise in a therapeutic area.
  • Capability to embrace new technologies.
  • Excellent communication, presentation, interpersonal skills, both written and verbal.
  • Willingness to travel when required (around 25%).

Get acquainted with Syneos Health


Over the previous 5 years, we have collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. Regardless of your position, you'll take the lead and challenge the existing state of affairs with us in a remarkably competitive and constantly evolving setting. Learn more about Syneos Health.


Additional Information:

Tasks, responsibilities, and duties listed in this job description are not exhaustive. The Company, at its sole discretion and without prior notice, may assign other tasks, duties, and responsibilities. Comparable experience, skills, and/or education will also be taken into consideration, so the qualifications of employees may differ from those specified in the Job Description. The Company, at its sole discretion, will determine what qualifies as equivalent to the qualifications described above. Furthermore, nothing herein should be interpreted as establishing an employment contract. Occasionally, essential skills/experiences for jobs are expressed briefly. All language herein is intended to fully comply with all obligations imposed by the legislation of each operating country, incorporating the implementation of the EU Equality Directive regarding the recruitment and employment of its workforce. The Company is committed to adhering to the Americans with Disabilities Act, including providing reasonable accommodations, when applicable, to support employees or candidates in performing the essential functions of the job.

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