Project Manager - Sponsor Dedicated (Inflammation)

Job Responsibilities

• Sr. Project Manager - Sponsor Dedicated (Inflammation)
• Location: Remote, USA

Role Summary

We are seeking a skilled and motivated Sr. Project Manager to join our sponsor-dedicated team supporting high-impact inflammation trials. In this role, you will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO-offering the best of both worlds: sponsor collaboration and CRO resources.

What You Will Do

• In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
• Communicates with functional peers regarding project status and issues and ensure project team goals are met
• Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.
• Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report
• Coordinates data review to support interim/final data analysis
• Participates in study strategy development.
• Maintains study timelines.
• Contributes to development of study budget.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management).
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
• Participates in the recruiting and hiring process for CPA/CTMAs and supports their professional development
• Coaches members of a work team and ensures adherence to established guidelines

Skills and Experience You Have

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
• Extensive Study Start-up Experience
• Global clinical trial experience
• Prior involvement in Inflammation studies
• Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
• Highly developed leadership skills to successfully lead a clinical study team
• Ability to deal with time demands, incomplete information or unexpected events
• Must display strong analytical and problem solving skills
• Attention to detail
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities

Additional information

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

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.

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.