Description

Clinical Study Manager I

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 SUMMARY
• The clinical study manager I is responsible for managing projects within the clinical division with a focal point of ensuring that protocols, procedures, client requests, prepare and seek approval for vendor purchase orders, manage timelines and subject safety are all adhered to.

JOB RESPONSIBILITIES
• Supervise and/or oversee all study-related procedures to ensure they are carried out in accordance with protocol and regulatory guidelines.
• Review draft protocol and coordinate operations in order to meet protocol requirements.
• Manage pre-defined study timelines and be proactive in identifying delays and possible solutions to meet deadlines.
• Manage complex clinical trials.
• Collaborate with other departments to create study specific procedures and forms as per guidelines.
• Lead and participate in continuous process improvement projects.
• Communicate the necessary risk and information to keep their team(s) and the organization abreast of their team's work plan, policies, projects, processes, results, actions and recommendations taken to meet arising needs.
• Review and approve the configuration of the Electronic Data Capture system
• Ensure questions and issues are addressed in a timely manner and provide reviewed study raw data for report completion.
• Perform review of clinical reports by utilizing protocol and procedural deviations reports and sample inventory.
• Represent their work units, both internally and externally, as to consultation and/or information and/or reference.
• Provide status updates regarding projects to clients and other departments.
• Ensure project files are complete and accurate.
• Participate in regulatory agency inspections and client audits that pertain to the specific projects at hand as well as the ensuing response process.
• Coordinate study monitoring visits.
• Act as a resource person for employees to ensure that procedures are adhered to, that work is of quality and follow-up are performed.
• Participate in the training of colleagues.
• May be assigned other clinical tasks.
• Supervise, coach, and mentor staff

Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges.

Additional Information

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.

The annual base salary for this position ranges from $50,760 to $95,900 USD/yr. 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.

COVID Policy: Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.

Qualifications

Position in Canada
• College degree or higher level degree in a related field.

Position in US
• Bachelor's degree in a related field or equivalent combination of education, training and experience.

Relative alternate certification may be considered acceptable.

This determination ensures the jobholder has sufficient technical ability to perform the role.

1 to 3 years of relevant work experience, preferable in the field of clinical study management

Must demonstrate good computer skills especially in the utilization of Microsoft Word, Excel and clinical software

Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

Knowledge of GCP/ICH guidelines and other applicable regulatory requirement

Experience within a client-service environment.

Position in Canada:
• English (level): Required bilingualism includes communicating verbally and in writing on topics that are often technical, and writing procedures or technical reports.

Position in US:
• Spanish level: Required bilingualism includes communicating verbally and in writing on topics that are often technical, and writing procedures or technical reports.

***Candidate who does not possess the required training and/or experience may be considered under different criteria.



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