Clinical Programmer II (Medidata RAVE EDC)

Syneos Health, Inc.; Madhapur; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Syneos Health is seeking a Clinical Programmer II with Medidata RAVE EDC expertise in Madhapur, India. The role involves designing, validating, and maintaining software for CRFs, databases, and reports, while collaborating with cross-functional teams on multiple clinical programming projects.

You will lead development activities, ensure quality deliverables, and support sponsor audits, with travel up to 25% as needed. A degree and 3+ years in Rave EDC are expected.

Qualifications

• Bachelor’s degree preferred, or equivalent combination of related education and experience.
• Minimum 3yrs of relevant experience in Rave EDC build experience is mandatory
• Must have experience in CRF build or screen build, edit checks programming
• Must have good knowledge about GCP, good clinical practices

Responsibilities

• Utilizes primary development tools including Oracle RDC, Oracle Inform, Medidata, Rave, SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
• Generates and maintains all required documentation, including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.
• Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback.
• Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• Ensures quality deliverables by providing review of study level core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits.
• Reviews and provides input on study budgets and monitors scope of work to actual work, alerting management of potential change orders.
• Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications, and uses expanded technical skills to meet evolving project needs.
• Assists in project review meetings and assists with departmental review meetings.
• Attends Quick Start Camps (QSCs) as the lead clinical programmer for assigned studies.
• Leads clinical programming activities on up to eight (8) concurrent studies depending upon scope, similarity, program, and resourcing requirements.
• Manages project resources, proactively alerting management of delivery and resourcing needs.
• Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.

Skills

Rave EDC build

CRF build

Edit checks programming

GCP knowledge

SAS

PL/SQL

Travel flexibility

Education

Bachelor’s degree or equivalent

Tools

Oracle RDC

Oracle Inform

Medidata

Job description

Clinical Programmer II (Medidata RAVE EDC)

Updated: Today
Location: Madhapur, TS, India
Job ID:25111430

Description

Clinical Programmer II (Medidata RAVE EDC)

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

• Utilizes primary development tools including Oracle RDC, Oracle Inform, Medidata, Rave, SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
• Generates and maintains all required documentation, including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.
• Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback.
• Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• Ensures quality deliverables by providing review of study level core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits.
• Reviews and provides input on study budgets and monitors scope of work to actual work, alerting management of potential change orders.
• Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications, and uses expanded technical skills to meet evolving project needs.
• Assists in project review meetings and assists with departmental review meetings.
• Attends Quick Start Camps (QSCs) as the lead clinical programmer for assigned studies.
• Leads clinical programming activities on up to eight (8) concurrent studies depending upon scope, similarity, program, and resourcing requirements.
• Manages project resources, proactively alerting management of delivery and resourcing needs.
• Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.

Qualifications

• Bachelor’s degree preferred, or equivalent combination of related education and experience.
• Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.
• Minimum 3yrs of relevant experience in Rave EDC build experience is mandatory
• Must have experience in CRF build or screen build , edit checks programming
• Must have good knowledge about GCP, good clinical practices
• Good to have Migration and Custom Function experience
• Experience working in a matrix-structured environment is preferred
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail
• Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred.
• Ability to travel as necessary (up to 25%)

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.

Summary

Leads, manages and supports project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.