Registry Management Associate Argentina or Mexico (Hybrid)

Registry Management Associate Argentina or Mexico (Hybrid)

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

Job Description

JOB TITLE:Registry Management Associate I

SELECT ONE: Clinical Solutions

JOB CODE:         SH1327

REPORTS TO:    Manager, Clinical Operations; or designee

Job Summary

The Registry Management Associate I (RMA I) is responsible for remote monitoring and research management activities for non-interventional studies collecting real world and late phase data. This includes non-site-based studies (e.g., pregnancy registries, retrospective chart review studies) as well as site-based non-interventional studies requiring remote tasks. In the Registry Coordinating Center (RCC), the RMA I is the primary contact for the Health Care Providers (HCPs)/sites and patients, as applicable, and responsible for providing support and customer service throughout the study lifecycle from start-up through closeout. The RMA I coordinates non-interventional study activities to ensure the integrity of data collected is in adherence with all applicable regulatory guidelines, Standard Operating Procedures (SOPs), Work Instructions (WIs), and Project Specific Operating Procedures.

Job Responsibilities

Study Coordination and Site Management

• Assures compliance with local regulations and appropriate guidance(s) depending on assigned study design.  May include International Conference on Harmonization (ICH), Good Clinical Practices GCP, Good Pharmacoepidemiology Practices (GPP), Good Epidemiologic Practices (GEP) guidelines, and Company and Sponsor SOPs. 
• Adheres to a schedule of data collection from HCPs/sites and patients.
• Assists with preparation for study meetings.
• Develops a rapport and maintains effective, accurate and timely communication with HCPs/sites, patients (if applicable), Sponsors, and project team.
• Conducts informed consent process and demonstrates diligence in protecting the confidentiality of each patient.

Study Documentation

• Maintains and ensures audit readiness of regulatory documentation according to Essential Regulatory Document Guidelines and Trial/Project Master File Plan. 
• Follows standard process for documentation of non-site based contacts (calls, written correspondence, etc.).
• Adheres to safety reporting requirements per protocol.

Remote Data Review

• Maintains timely completion and submission of Electronic Case Reports Forms (eCRFs) in accordance with study-specific project and data management plans.
• Reviews completed eCRFs and resolves queries and/or other identified data collection issues.
• Performs data collection, data review, and direct data entry from call center-based interviews and inbound data forms.

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.

http://www.syneoshealth.com

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.