Senior Clinical Data Associate

7 days ago

India inVentiv Health Clinical SRE, LLC Full time
Job Description

Description

Sr Clinical Data Manager (DAS)

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

Responsible for project management of all the data management services for the assigned projects. Ensures the contracted Data Management activities for projects are carried out by the Company in accordance with the executed contract and the Sponsor's expectations

Job responsibilities

- Leads the collection of non-CRF data, during study set-up, conduct and close out activities for multiple studies, contributing to fit for purpose data quality. Including IxRS data loaded into the eCRF.
- Close collaboration with the non-CRF vendors/data providers to set up data transfer agreements and ensure timely and quality non-CRF data delivery. Come to mutual agreements and intelligently negotiate with the vendor and study team to be able to deliver what the study needs.
- Selects and implements appropriate study conventions including non-CRF data collection standards, processes, knowledge sharing and best practices on assigned study(s).
- Proactively develops study level project plans (including contingency plans) to ensure timely delivery of quality non-CRF study data to support project milestones.
- Represents Data Management Group on Study working groups or sub-teams and works with the study team to develop and implement specifications and processes related to non-CRF vendors/data providers.
- Effectively communicates non-CRF data collection deliverables, status of work and data issues to the DQL and other study team members. Coordinates cross-functional non-CRF tasks with strong understanding of downstream processes and stakeholder needs and impacts.
- Identifies the need for new processes and guidance documents.
- In-depth understanding of the business of his or her discipline and the wider Data Management Group.
- Understand the conceptual basis for data management conventions, standards and processes.
- Good understanding of the role of data management, biostatistics, statistical programming and the study team in the drug development process.
- Understands compliance, regulatory principles and follow GxP requirements (SOPs, Policies etc).

Qualifications

What we're looking for

- BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
- Should have 5+ years of experience in End-to-End Clinical Data management activities, Non CRF data handling along with min 4 years of core DAS experience
- Able to understand complex interdependencies.
- Communicate independently, proactively and clearly to internal and external stakeholders, able to work autonomously on the non-CRF data strategy for the study team. Take ownership of non-CRF data.
- Identify risks and suggest mitigation plans.
- Influence the study team to adhere to (non-CRF principles) and processes, speak up and challenge where necessary.
- Negotiate contingency plans to mitigate delays of deliverables.
- Can demonstrate curiosity for data and be able to learn fast and think smart.
- Scientific background in at least one of the following: medical, biological, lab, imaging, life sciences.
- Comfortable with working across multiple platforms and tools.

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 .

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.

#LI-DNI

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