Description
Site Start-Up & Regulatory Specialist II
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.
Under the guidance of the Director of Global Site Management & Central Services, this position will be responsible for conducting end-to-end site management from feasibility to site activation serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and all study and site start-up, maintenance and close-out activities.
Duties And Responsibilities
- Assist in development of in-house model process documents.
- Serve as an In-House Study Lead, a primary point of contact to study team on end-to-end study activity.
- Lead In-House Study team meetings as appropriate.
- Participate in In-House Study Management meetings.
- Utilize tools to track activities and develop reports.
- Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires.
- Oversee site contract/budget negotiations (Confidentiality Agreements, Clinical Trial Agreements and Ancillary Agreements).
- Oversee essential document collection, tracking & review.
- Support the collection of country and site level intelligence.
- Support Ethics Committee and Regulatory Authority submissions.
- Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a study as appropriate.
- Assist in the development of In-House study processes and procedures.
Qualifications
What we’re looking for
- Qualifications (Minimal acceptable level of education, work experience, and competency)
- Bachelor’s Degree in Business Administration, Finance, science or related field.
- Strong back in Study Start-up in the biopharmaceutical/CRO industry.
- Flexibility to assume a workload, which frequently necessitates an adjustment of priorities.
- Goal oriented, self-starter with proven ability to work independently.
- Able to proactively identify issues and provide potential solutions for resolution.
- Detail oriented.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
- Proficiency with Veeva Vault and all applications of Microsoft Office.
- Good interpersonal skills.
- Comfort with ambiguity; ability to act without having the total picture.
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to understand clinical protocols and associated study specifications.
- Detailed understanding of clinical trial start-up processes.
- Ability to manage external vendors to contract effectively.
- Strong organizational skills with ability to handle multiple tasks effectively.
- Strong written and verbal communication and interpersonal skills.
- Ability to manage multiple project budgets with increased complexity and value.
- Quality-driven in all managed activities.
- Good negotiating skills.
- Good problem-solving skills.
- Demonstrated ability to work independently as well as part of a team.
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.
