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

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Are you passionate about advancing women's cancer research and driving impactful clinical trials? We are seeking a Clinical Project Manager II to join a high-performing, sponsor-dedicated team supporting cutting-edge clinical development programs focused on gynecologic malignancies.

This is a fully remote, US-based opportunity where you will play a key role in the operational execution of clinical studies. Prior Oncology clinical trial experience is required, and direct experience supporting gynecologic malignancy indications is required.

As a Clinical Project Manager II, you will support and help drive the operational conduct of clinical trials, contributing to study execution and delivery excellence:

• 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

REQUIRED QUALIFICATIONS

• 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

REQUIRED THERAPEUTIC AREA EXPERIENCE

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

Examples of relevant experience include clinical trials supporting gynecologic oncology programs, women's oncology studies, or investigational therapies for ovarian, cervical, endometrial, uterine, vaginal, vulvar, fallopian tube, or primary peritoneal cancers.

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.**

PREFERRED QUALIFICATIONS

• 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

KEY SKILLS & COMPETENCIES

• Strong organizational and coordination skills

• Excellent communication and stakeholder management abilities

• Ability to manage multiple priorities and timelines in a fast-paced environment

• Detail-oriented with a focus on quality, compliance, and execution

• Strong collaboration skills within cross-functional and global teams

EDUCATION

• Bachelor's degree (or higher) in a scientific, healthcare, or related field

• Plus 2+ years of clinical trial Project Management experience

• Work on innovative gynecologic malignancy clinical trials that make a meaningful difference in patients' lives

• Support research advancing treatment options across ovarian, cervical, endometrial, uterine, vaginal, vulvar, fallopian tube, primary peritoneal, and other gynecologic malignancies

• Be part of a collaborative, sponsor-dedicated team

• Enjoy the flexibility of a 100% remote role (US-based)

• Expand your impact across end-to-end clinical study delivery

At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.  Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.