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20 days old

Project Manager

Lupus Therapeutics, an Affiliate of Lupus Research Alliance
Arlington, Virginia

The Lupus Research Alliance (LRA) is the largest non-profit organization leading the world in innovative research to improve the lives of those living with lupus today and to prevent and cure lupus tomorrow. The LRA organized a Lupus Clinical Investigators Network (LuCIN) to facilitate the clinical study of new and existing therapies to treat, cure, and ultimately prevent lupus. The LRA incorporated an affiliate, Lupus Therapeutics, LLC, to manage the business of affairs of LuCIN and the organization’s clinical trial endeavors.

Position Summary:

The Lupus Therapeutics Project Manager (PM) is responsible for the management of all aspects of Clinical Trial activities for assigned project(s). The PM, in concert with the Director of Clinical Operations, is accountable for achieving successful delivery of clinical trial and Network-wide activities according to time, quality/scope and budget constraints. The PM position will perform a wide variety of activities to support the study start-up and completion of clinical research studies being conducted within LuCIN and in partnership with the biopharmaceutical industry.

The position reports directly to the Lupus Therapeutics Executive Director and is based in Arlington, Virginia.

*_Important: To apply please send a cover letter, salary requirements and resume to HR
_*

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:

  • Proactively manage project level operational aspects of clinical trials including management of trial timeline, budget, resources, sites and vendors.
  • Provide efficient updates on clinical trial progress to the Director of Clinical Operations Director and Executive Director.
  • Lead the study start-up process, including but not limited to conduct of the site selection/feasibility and finalization of site and Clinical Trial Agreements and budgets.
  • Ensure effective project plans are in place and operational for each trial and work proactively with the sponsor to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
  • Ensure potential study risks are escalated to the attention of the Director of Clinical Operations when appropriate.
  • Organize/Lead clinical trial status/update meetings and ensure meeting minutes are completed, distributed to team members and filed.
  • Monitor the quality of project deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the site clinical team.
  • Review and approve site invoices in collaboration with the Finance team to ensure investigator payments occur in a timely manner.
  • Ensure all project level study documentation is filed in accordance with company SOPs.
  • Effectively provide support to Site clinical staff in the conduct of the trials
  • Assist in follow-up business development activities as needed.
  • Communicate effectively with Network leadership, clinical sites, investigators and biopharmaceutical industry partners.
  • Other duties as assigned.

Education/Experience: The ideal candidate will offer:

  • Bachelor’s degree in Life Sciences, Nursing Licensure or Pharmacy, at minimum
  • Four or more years of clinical operations experience for PM; with increasing levels of responsibility, in the Academic Medical Center, Pharmaceutical, Biotechnology, or CRO industry is required.
  • Five or more years of project management experience at an Academic medical center, sponsor or CRO company is preferred.
  • Therapeutic experience in autoimmune diseases and/or Lupus (preferred)
  • Experience in early phase trials (Phase I-II) (preferred)

Knowledge, Skills and Abilities:

  • Read, write and speak fluent English; excellent verbal and written communication skills
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.

Work Environment: This is a high growth, fast paced entrepreneurial organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically is required, it is anticipated that this will be less than 25% of work time.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

No phone calls please.

For information about the Lupus Therapeutics, please visit our website: www.lupustherapeutics.org

Job Type: Full-time

Salary: $60,000.00 to $75,000.00 /year

Experience:

  • Project Management: 5 years (Required)
  • Clinical Trial Operations: 4 years (Required)
  • ICH Guidelines: 1 year (Preferred)
  • Clinical Research: 1 year (Preferred)
  • FDA Regulations: 1 year (Preferred)

Education:

  • Bachelor's (Required)

Location:

  • Arlington, VA (Preferred)

Language:

  • English (Required)

Benefits offered:

  • Paid time off
  • Health insurance
  • Dental insurance
  • Healthcare spending or reimbursement accounts such as HSAs or FSAs
  • Other types of insurance
  • Retirement benefits or accounts
  • Employee discounts
  • Workplace perks such as food/coffee and flexible work schedules

Categories

Posted: 2019-05-01 Expires: 2019-05-31

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Project Manager

Lupus Therapeutics, an Affiliate of Lupus Research Alliance
Arlington, Virginia

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