Clinical Project Manager II – Oncology - Gynecologic Malignancies experience required (Sponsor Dedicated / Remote – US)

Syneos Health is a leading fully-integrated life sciences services organization dedicated to accelerating customer success. They are seeking a Clinical Project Manager II to support operational execution of clinical trials focused on gynecologic malignancies, requiring prior oncology clinical trial experience. The role involves managing day-to-day clinical trial operations and collaborating with cross-functional teams to achieve study milestones.

Responsibilities:

• Support the Study Lead and cross-functional study team in day-to-day clinical trial operations
• Support activities such as:
• Clinical Trial Team (CTT) meeting coordination and minutes
• Clinical supplies planning and tracking
• Lab specimen tracking and reconciliation
• Imaging data reconciliation
• Study status reporting and updates
• Study closeout activities
• Contribute to single or multiple studies, depending on scope and complexity
• Lead smaller or limited-scope studies, as appropriate (e.g., survival follow-up studies)
• Track and manage study timelines using project management tools
• Collaborate with internal stakeholders and external partners, including investigative sites, vendors, and committees
• Support achievement of study milestones and clinical objectives

Requirements:

• Minimum 2 years of pharmaceutical and/or clinical drug development experience within the last 5 years (e.g., biopharma, CRO, SMO, hospital, clinical research site, or trial unit)
• Clinical Project Management experience in Oncology is required
• Direct experience supporting Gynecologic Malignancy clinical trials is required
• Vendor management experience is required
• Strong working knowledge of clinical trial operations and execution
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Good understanding of ICH-GCP and clinical research processes
• Ability to work effectively in a matrix environment
• Candidates must have direct clinical trial experience supporting one or more of the following gynecologic malignancies: Ovarian Cancer, Cervical Cancer, Endometrial (Uterine) Cancer, Uterine Sarcoma, Vaginal Cancer, Vulvar Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Other Gynecologic Malignancies
• Candidates should be able to clearly articulate their experience supporting these disease areas, including the indication(s), study phase(s), sponsor or organization, and their specific role and responsibilities within the clinical trial
• CANDIDATES WITHOUT DIRECT EXPERIENCE SUPPORTING GYNECOLOGIC MALIGNANCY CLINICAL TRIALS CAN NOT BE CONSIDERED
• Bachelor's degree (or higher) in a scientific, healthcare, or related field
• Plus 2+ years of clinical trial Project Management experience
• Phase II–III clinical trial experience
• Experience supporting multiple gynecologic malignancy indications
• Exposure to MS Project or similar project management tools
• Familiarity with systems such as: CTMS/eTMF (e.g., Veeva Vault), IRT/IVRS platforms