Manager, Project Support Services

2 tygodni temu

Warszawa, Mazovia, Polska Precision for Medicine Pełny etat

Precision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

Due to continued growth we are currently seeking The Manager, Project Support Services to provide line management to PSS's and Sr. PSS's and develop robust and flexible methodologies to optimize the administrative support provided to project teams.

Essential functions of the job include but are not limited to:

  • Develop, mentor, manage and coach PSS staff to progress their skills so that Precision's quality standards are maintained. Advocate individual career development, and individual responsibility/accountability
  • Ensure PSS personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
  • Participate in the interview process for new PSSs by conducting CV review and participating in the interviewing process.
  • Conduct on-boarding training for new PSS staff in conjunction with Human Resources, clinical Training and other functional areas
  • Develop robust and flexible operational methodologies, standards and processes for the PSS role and ensure consistent, quality execution among the PSS personnel
  • Ensure that PSS personnel have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
  • Develop training plans and hold personnel accountable to achieving training goals or addressing training needs
  • May serve as a member of the Project Team and perform the job duties of a Sr. PSS
  • May assist with study start-up of clinical trials, including feasibility, investigator recruitment, and general site management support
  • Perform other duties as assigned by management
  • Manages workload of supervised staff with continued assessment and adjustment as needed
  • Provides on-going feedback, development and coaching of PSSs including annual performance reviews
  • Mentors and trains PSSs in clinical study monitoring and the relevant applicable regulations, ICH-GCP Guidelines; ensures standards for monitoring and reporting are met

Qualifications:
Minimum Required:

  • Graduate of a secondary education or equivalent degree required
  • At least 5 years of clinical research experience

Other Required:

  • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
  • Strong communication and interpersonal skills to effectively interface with others in a team setting
  • Strong organizational skills, attention to detail, and a customer service demeanor
  • Ability to travel domestically and internationally including overnight stays

Preferred Requirements:

  • Prior line management experience
  • PSS experience

Competencies:

  • Demonstrates a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
  • Resolves project related problems and prioritizes workload to meet deadlines with little support from management
  • Solid working knowledge of eTMF platforms
  • Solid interpersonal skills
  • Motivates other members of the project team to meet timelines and project goals
  • Exhibits high self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
  • Ability to develop, coach and mentor PSS staff
  • Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient
  • Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders
  • Communicates both verbally and in written form in an efficient and professional manner
  • Demonstrates a values and work ethic consistent with Precision Values and Company Principles

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

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