Project Specialist

Description

Project Specialist ( Hyderabad/ Gurgaon)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Job Responsibilities

• Minimum 1 year of experience in clinical research and core project management.
• Strong proficiency in Advanced Microsoft Excel.
• Support project coordination, reporting, and data management activities.
• Maintain accurate and up-to-date process documentation.
• Communicate effectively with internal and external stakeholders.
• Finance and budgetary knowledge are a plus.
• Candidate from Hyderabad and Gurgaon preferred
• Planning, directing, creating, and communicating clinical study timelines, ensuring that all milestones are met and that the project stays on track
• Gathering input from cross-functional teams, including clinical, regulatory, and data management, to create comprehensive plans for timely deliverables
• Ensuring consistency of clinical study processes across trials by standardizing procedures and implementing best practices
• Overseeing and resolving operational aspects of clinical trials, including addressing any issues that arise during the study and ensuring that all activities are conducted in compliance with SOP, GCP, and specific country regulations
• Selecting sites and vendors for clinical trials, negotiating contracts, and managing relationships to ensure high-quality and timely delivery of services
• Preparing clinical trial budgets, monitoring expenditures, and ensuring that the study remains within budget
• Monitoring progress of clinical trials, tracking key performance indicators, and following up with team members and line managers to address any deviations from the plan
• Implementing and preparing the clinical development strategy as outlined by the clinical teams, ensuring alignment with overall project goals and objectives
• Developing trial recruitment strategies, including identifying target populations, creating recruitment materials, and monitoring enrollment progress

Qualifications:

• High school diploma or equivalent required
• Associate's degree or higher in a related field preferred
• Minimum of 3 years of experience in clinical project management or a related field
• Strong understanding of clinical trial processes and regulations
• Experience with SOP, GCP, and country-specific regulations

Certifications:

• Certification in Clinical Project Management or related field preferred
• Good Clinical Practice (GCP) certification preferred

Necessary Skills:

• Excellent organizational and time management skills
• Strong communication and interpersonal skills
• Ability to work effectively in a team environment
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Attention to detail and problem-solving skills
• Ability to adapt to changing priorities and work under pressure

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. 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.

Summary

Roles within Clinical Project Management at the S11 level are responsible for planning, directing, creating, and communicating clinical study timelines. These roles gather input from cross-functional teams to create plans that help the team produce deliverables on schedule. Individuals ensure consistency of clinical study processes across clinical trials, overseeing and resolving operational aspects in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. This includes site and vendor selection, preparing clinical trial budgets, and ensuring studies are conducted within clinical trial protocols. The roles involve monitoring progress and following up with team members and line managers when issues develop. Additionally, individuals implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies.Impact and ContributionIndividuals in these roles significantly impact the success of clinical trials by ensuring that all aspects of the study are conducted efficiently and effectively. By creating and communicating clear timelines and plans, they help the team stay on track and meet deliverables on schedule. Their oversight of operational aspects and adherence to SOP, GCP, and country regulations ensures the integrity and quality of the clinical trials. Their contributions to site and vendor selection, budget preparation, and strategy implementation are crucial for the smooth execution of clinical studies. Their ability to monitor progress and address issues promptly helps maintain the momentum of the trials and supports the overall clinical development strategy.Core Focus
•Planning, directing, creating, and communicating clinical study timelines
•Gathering input from cross-functional teams to create plans for timely deliverables
•Ensuring consistency of clinical study processes across trials
•Overseeing and resolving operational aspects of clinical trials
•Adhering to SOP, GCP, and specific country regulations
•Selecting sites and vendors for clinical trials
•Preparing clinical trial budgets
•Monitoring progress and following up with team members and line managers
•Implementing and preparing the clinical development strategy
•Developing trial recruitment strategies