Description

Sr Clinical Operation Specialist/ Lead Clinical Operation Specialist (immediate Joiner)

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

• 7-8 years of relevant CTA experience
• CTA experience combined with centralized monitoring exposure is preferred
• Home-based position with immediate joiners strongly preferred
• Strong operational understanding of clinical research
• Good communication skills and fluency in English
• Must be proactive, resourceful, and a quick learner

• roles and responsibilities.

• Support set-up and maintenance of information in Clinical Trial Management Systems and other systems as applicable, independent or under the responsibility of (Sr.) Clinical Project Manager as applicable: Update data, timelines, milestones, Ethics Committee /

• Health Authority authorizations, etc. on an ongoing basis.

• Support (Sr.) CPM with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable. Perform Good receipt booking in line with Vendor financial report and study status, as required.

• Support set-up and maintenance of Trial Master File: Ensuring that all key documents are present and filed as appropriate in TMF, independent or under responsibility of (Sr.) CPM as applicable. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.

• Track clinical studies/projects/activities progress, ensure CTMS, TMF and other systems as applicable are up to date. Address questions escalate issues or critical findings to project lead (Sr./CPM).

• Support in External Service Provider coordination:

1.Support (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation andmaterial in place for clinical study/projects/activities at start, conduct and close-out.

2.Follow-up with External Service Providers on day-to-day operations

3.Ensure all data is reported to the Clinical Trial Team (CTT) and available to business colleagues

4.Logistical support to study team (internal and external) onboarding process

• Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation.

• Support CTT in study start-up activities, recruitment and close-out activities as required.

• Champion the implementation of operational changes and transitions as required.

• COS may additionally support below activities as deemed necessary by reporting manager or Head CPM:

1. Responsible for developing monitoring plans and study specific tools as applicable

2. Provide input to eCRF design & review, and other documents and systems, as applicable

3. Responsible for central monitoring and data oversight on assigned clinical study(s) using available online data sources (eCRF, IRT, central lab, etc.) to ensure consistency, plausibility, completeness and correctness of the data

4.Communicate any observations, deviations to protocol, safety alerts, quality issues, trend/patterns, risk factors etc. to the clinical team and CRAs for timely follow-up of actions and issue resolution

5. Collaborate with Medical Lead to identify any safety trends, is a key team member of the ClinicalTrial Team and will lead the discussion in Data Review Team (DRT) meetings

6.Prepare and share the Central Monitoring Package where applicable and agreed with the CRAs prior to monitoring visits

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.

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

JOB SUMMARY The position is responsible for providing clerical, technical and administrative support to one or more business units or clients within Clinical Operations. Provides overall study support to functional leads to ensure the successful completion of project deliverables. Mentors and/or trains less experienced staff.