Sr. Project Manager - Clinical Research

Job Description

Job Description

Software Guidance & Assistance, Inc., (SGA), is searching for an Sr. Project Manager for a Contract assignment with one of our premier Healthcare clients working remote PST hours.

Responsibilities :
The Senior Project Manager (Sr. PM) of the Clinical Trials Development (CTD) Team will participate in all Investigator Initiated Trial (IIT) research activities as part of the clinical research team within the Department of Medicine, Division of Hematology Oncology at the firm.
Working under the direction of investigators and Senior Management of the Clinical Research Unit (CRU), including the Faculty Director, Director of Research, Medical Director, and Director of Finance and Administration, the Sr. PM will provide project management support and oversight for assigned investigator-initiated clinical research studies.

• Serve as the primary point of contact for investigators, regulatory coordinators, study coordinators, data managers, research staff, and study monitors.
• Provide project management support and oversight for assigned investigator-initiated clinical research studies.
• Ensure accurate and timely writing of protocols and study documents.
• Assist with the preparation and completion of FDA IND, DSMB, IRB, and other regulatory submissions.
• Review and follow up on study data and monitoring findings.
• Assist with maintaining regulatory files to fulfill research requirements and meet established study timelines.
• Collaborate with study teams and study monitors to support data quality.
• Ensure study documentation is complete, accurate, and maintained in a timely manner.
• Manage assignments from the team Director and study investigators, adjusting priorities based on study and departmental needs.
• Ensure studies and patient care needs are addressed appropriately and in a timely manner.

Required Skills :

• Experience or demonstrated ability in clinical research project management, preferably involving Investigator Initiated Trials (IITs).
• Knowledge of clinical research protocols, study documentation, and regulatory processes.
• Familiarity with FDA IND, DSMB, IRB, and other regulatory submissions.
• Ability to review study data, address monitoring findings, and maintain accurate regulatory documentation.
• Strong organizational and time management skills, with the ability to meet established study timelines.
• Ability to work independently and collaboratively with multidisciplinary research teams.
• Strong written communication skills, particularly in protocol and study document preparation.
• Excellent interpersonal and communication skills to coordinate with investigators, research staff, and study monitors.
• Ability to manage multiple assignments and adjust priorities based on changing study and departmental needs.
• Strong attention to detail and commitment to maintaining data quality and documentation accuracy.

By applying for a job with SGA, you agree to allow SGA to process your application for this and future opportunities in accordance with our Privacy Policy. Also, to ensure timely processing, you agree to be contacted by our AI recruiter via email, text, or phone. Message frequency varies and data rates may apply, but you can reply STOP to any SMS message to opt-out of texts and may contact SGA at View email address on ziprecruiter.com to opt-out of AI communications. The choice not to engage with AI will not adversely impact your consideration for placement. AI is not used to make any hiring determinations.

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.