Manager, Project Support Services
2024-05-18
Romania
Pfm
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.
#LI-Remote
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
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.
#LI-Remote
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].