Clinical Study Administrator, Country Operations Management

Syneos Health

About The Position

Clinical Study Administrator, Country Operations Management 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 Clinical Study Administrator Location: Boston, MA (Seaport area) Role Summary: We are seeking a skilled and motivated CSA to join our sponsor-dedicated team supporting rare disease trials. In this role, you will work full-time on behalf of a leading sponsor while employed within a global CRO - offering the best of both worlds: sponsor collaboration and CRO resources. What You Will Do: The CSA collaborates closely with the Project Manager Country Operations and other local study team members such as the Study Start Up manager, Clinical Research Associates, Site Management Leads and Head of Country Operations in delivering support in the conduct of clinical trials in region or country. You will be responsible for: • Providing support to the local study team in COM in achieving quality and timeliness of study deliverables across the lifecycle of assigned trials (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) • End to end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, tracking of team training documentation, milestone management in the Clinical Trial Management System (CTMS) and other general trial support in the country or region as delegated or per assigned trials. • Providing support to the local study team including for start up activities in start-up phase: CDA delivery and negotiation, distribution and collection of documents, communication with sites during contract negotiation phase, Site File preparation and preparation and approval of sites for activation, etc • Collaborating with PMCO, CRAs, SSU manager and study vendors on the preparation, supports the handling and distribution of clinical trial supplies and maintenance of tracking information • Act as a central point of contact for the local study team in COM for designated project communications, correspondence, and associated documentation. • Input on the development and maintenance of project management and other global tracking tools (e.g: CTMS, smartsheets, etc). • Collaborating in global initiatives to standardize processes within and across countries (collaboration with other local and global CSAs) • Assist with local language translations, IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions, as required within the country/region. • Providing support to local COM team with local F2F study and team meetings (venue, cost, agenda, etc), support team teleconferences, assist with staff onboarding as required by country/region Skills and Experience You Have:

Requirements

Bachelor's Degree in a related discipline, preferably life science.
Proficiency with MS Office Suite (excel, word, powerpoint)
Understanding of the drug development process either via education or experience in the life sciences field.
1+ years of experience in the pharmaceutical industry working with delivery of clinical studies.
Excellent collaboration and interpersonal skills, unafraid to ask questions.
Strong organizational skills and ability to manage competing priorities.
Strong attention to detail
Effective written and verbal communication skills

Responsibilities

Providing support to the local study team in COM in achieving quality and timeliness of study deliverables across the lifecycle of assigned trials (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation)
End to end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, tracking of team training documentation, milestone management in the Clinical Trial Management System (CTMS) and other general trial support in the country or region as delegated or per assigned trials.
Providing support to the local study team including for start up activities in start-up phase: CDA delivery and negotiation, distribution and collection of documents, communication with sites during contract negotiation phase, Site File preparation and preparation and approval of sites for activation, etc
Collaborating with PMCO, CRAs, SSU manager and study vendors on the preparation, supports the handling and distribution of clinical trial supplies and maintenance of tracking information
Act as a central point of contact for the local study team in COM for designated project communications, correspondence, and associated documentation.
Input on the development and maintenance of project management and other global tracking tools (e.g: CTMS, smartsheets, etc).
Collaborating in global initiatives to standardize processes within and across countries (collaboration with other local and global CSAs)
Assist with local language translations, IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions, as required within the country/region.
Providing support to local COM team with local F2F study and team meetings (venue, cost, agenda, etc), support team teleconferences, assist with staff onboarding as required by country/region

Benefits

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
flexible paid time off (PTO) and sick time

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