Project Support Specialist II New Remote, Canada

Precisionscientia; Canada; Remote; CAD 45,000 - 75,000; Full time

Job summary

Join a forward-thinking organization as a Project Support Specialist II, where you will play a vital role in managing project timelines and supporting cross-functional teams. This role offers the opportunity to enhance your project management skills while collaborating with diverse teams to ensure project success. You will be responsible for scheduling meetings, maintaining project documentation, and ensuring compliance with training requirements. If you are detail-oriented and possess strong communication skills, this is your chance to contribute to impactful projects in a dynamic environment.

Qualifications

• 4+ years of relevant experience in project support or management.
• Strong proficiency in Microsoft Office and project management tools.

Responsibilities

• Manage meeting lifecycle and project timelines effectively.
• Assist in training management and vendor coordination.

Skills

Microsoft Office

Customer Service

Interpersonal Skills

Critical Thinking

Detail Orientation

Communication Skills

Education

4-year college degree or international equivalent

Tools

MS Project

SharePoint

Job description

The Project Support Specialist II (PSS II) serves as a member of the project team providing cross-functional support with the goal of contributing toward efficient management of the studies to which they are assigned. The PSS II is a solid team member who can execute, with some oversight, all core responsibilities consistently across several studies using independent judgment and critical thinking. The PSS II effectively collaborates with their cross-functional team members and will take on new or expanded responsibilities when appropriate and with proper training. The PSS II prioritizes their work and collaborates with the project team to ensure a consistent understanding of the timing for completion of work products.

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

• Manages the meeting lifecycle including scheduling internal and external meetings, preparing, and circulating agendas, taking meeting minutes, circulating, and updating meeting minutes based on team member input, and filing meeting agendas and minutes in the Trial Master File.
• Assists with creation and maintenance of the project timeline in MS Project or similar system. Collects updates from team members, captures and documents these updates, and ensures updates are communicated to the cross-functional study team.
• Performs an array of activities and tasks in clinical systems applicable to their role and project scope..
• Manages study-specific training lifecycle by collecting, tracking, and loading training materials, assigning team members to appropriate training, and documenting completion of study-specific training in appropriate systems. Manages the maintenance of training records and files records in the Trial Master File.
• Identifies gaps in training by reviewing team member training compliance on a defined periodic basis and engages appropriate team members to ensure training completeness. Escalates to the Project Manager as needed.
• Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors, and others as appropriate.
• Creates project-specific email boxes and maintains appropriate access to study team members.
• Manages user access to study systems by submitting user requests to the Helpdesk or similar, by reviewing team member access on a defined periodic basis, and documenting access reviews. Ensure rapid removal of system access for team members no longer affiliated with the study.
• Orders study supplies and addresses queries on study supplies.
• Prepares study binder materials and works with vendor to ensure proper binder creation and shipping to study sites. Works with vendor to obtain project-related cost estimates. Ensures vendor quotes align with invoices for completed binders and consults directly with Project Manager to approve vendor payments.
• Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager, or other project leader.
• Manages the addition and removal of project team members in the finance system, including assignment of team members to specific tasks for time tracking.
• Reviews and approves weekly time reporting by team members. Identifies and escalates time reporting concerns to the Project Manager.
• With oversight by the Safety Lead, supports the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable.
• Manages the translation of site level documents, as applicable, per local and regional standards through document collection, tracking, vendor collaboration, engagement of stakeholders to evaluate translation completeness and vendor payments.
• Supports the management of project-specific vendors by assisting with development of the Vendor Management Plan, providing vendors with project trainings and access to systems, tracking vendor issues and overseeing vendor invoicing and payments.
• Manages the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable.
• Supports the Project Manager with the production of various study plans, reports and updates (e.g., PM plan, country/site initiation, activation, recruitment) including preparing initial drafts, managing the collection of team member input, and finalizing content.
• Collects data and maintains monthly Key Performance Indicators (KPIs) and project health data. Circulates data to the Project Manager and internal team members as appropriate.
• Collects functional team input for the quarterly inspection readiness review.
• May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment).
• Supports the Project Manager in the creation and maintenance of the Sponsor-facing study story board.
• Supports the Project Manager in tracking out of scope work. Prepares, with guidance, materials required for the submission of change orders.
• Performs other duties as assigned by the Project Manager.

Qualifications:

• 4-year college degree or international equivalent; or equivalent experience ideally in a business, scientific or healthcare discipline
• Minimum 2 years relevant experience or demonstrated competencies in the key requirements of the role.

Other Required:

• Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level).
• Working knowledge of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Strong written and verbal communication skills
• Commitment to performing professionally consistent with Precision Principles.

Any data provided as a part of this application will be stored in accordance with ourPrivacy Policy. For CA applicants, please also refer to ourCA 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.

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 [e-mail] .

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Apply for this job

*

indicates a required field

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

School Select...

Degree Select...

Select...

Start date year

LinkedIn Profile

What is your desired salary? *

Are you authorized to work lawfully in the country/location for which you are applying? * Select...

Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status. * Select...

Have you ever worked for Precision Medicine Group or one of its affiliated companies? * Select...

If yes, when and which company?

Have you ever interviewed with Precision Medicine Group or an affiliated company? * Select...

If yes, when and which company?

Are you currently subject to a Non-Compete or Non-Solicit with your current employer? * Select...

I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge.If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment.I authorize the Company or its agents to confirm all statements contained in this application and/or resumes as it relates to the position I am seeking and to the extent permitted by federal, state, or local law. I agree to complete any required authorization forms for the background investigation.I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by federal, state, and local law, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information.If hired I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the United States. I also understand that the Company employs only individuals who are legally eligible to work in the United States.This application will remain active for 60 days. Any applicant wishing to be considered for employment after that time must reapply.UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. * Select...