Project Support Specialist II

Precision Medicine Group; United States; On-site; USD 58,000 - 88,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Project Support Specialist II to provide essential support in the management of clinical studies. In this role, you will collaborate with cross-functional teams to ensure project timelines are met while executing core responsibilities with independent judgment. Ideal candidates will hold a 4-year college degree and possess at least 3 years of relevant experience, along with strong communication and teamwork skills.

Benefits

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Qualifications

• Minimum of 3 years of relevant experience.
• Fluency in the Microsoft Office package required.
• Ability to communicate proficiently in English.

Responsibilities

• Schedules meetings and prepares agendas.
• Creates and maintains project timelines.
• Orders study supplies and maintains study trackers.

Skills

Customer service demeanor

Attention to detail

Communication skills

Teamwork

Education

4-year college degree

Tools

Microsoft Office

Job description

Position Summary

The Project Support Specialist 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 Project Support Specialist II provides support on projects with some oversight. The Project Support Specialist II (PSS II) is a solid team member who can execute 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.

Position Summary

The Project Support Specialist 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 Project Support Specialist II provides support on projects with some oversight. The Project Support Specialist II (PSS II) is a solid team member who can execute 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:

• Schedules internal and external meetings, assists with preparing and circulating agendas, takes meeting minutes, circulates meeting minutes, and files meeting agendas and minutes in the Trial Master File.
• Creates and maintains the project timeline in MS Project or similar system. Ensures updates are captured and documented. Ensures the distribution of updates to study team members.
• Performs an array of activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating study contact lists, maintaining enrollment projections as needed, and submitting helpdesk tickets and ensuring remediation is completed.
• Prepares, assigns, and documents study-specific training in appropriate systems; manages and oversees the maintenance of training records. Identifies gaps in training and engages appropriate team members or escalates 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 define periodic basis, and document access review.
• Orders study supplies and addresses queries on study supplies.
• Orders initial study binders. Collects, collates and prepares study binders and ensures shipping to the proper locations through printing vendor.
• Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager or other project leader.
• Sends communications to study sites, investigators and others, as directed by the Project Manager, Clinical Trial Manager or other Project Leadership, including SUSARs, email blasts, newsletters and other information that may be required.
• May support 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, may be under Safety staff guidance.
• May support the translation process of site level documents, as applicable, per local and regional standards.
• May act as point of contact for project-related requests for team members, Sponsors, and third- party vendors.
• Supports the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable.
• May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment).
• Performs other duties as assigned by the Project Manager, Clinical Trial Manager or other Project Leadership.
  
  

Qualifications

Minimum Required:

• 4-year college degree, or equivalent experience ideally in a business, scientific or healthcare discipline
• Minimum of 3 years of relevant experience.
  
  

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).
  
  

Competencies

• 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.
  
  

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$58,400—$87,600 USD

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.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Pharmaceutical Manufacturing

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