Senior Clinical Data Manager - Operations

工作内容

Role: Senior Clinical Data Manager
Locations: Hyderabad/Bangalore/Noida
Shift: 4pm - 1am IST

Are you ready for the Most Impactful Work of Your Life?
Signant Health is a global evidence generation company. We’re helping our customers digitally enable their clinical trial programs, meeting patients where they are, driving change through technology and innovations and reimagining the path to proof. Working at Signant Health puts you in the very heart of the world’s most exciting sector - a high-growth, dynamic company in an extraordinary industry. We innovate the leading-edge of clinical research data. We do it faster, better and with an eye on the future of our industry.

Role Purpose
The Senior Clinical Data Manager is responsible for working with the Clinical Data Management team and other internal project team members to provide data management services for our customers to ensure on time and accurate deliverables. Responsibilities include providing data management guidance to internal project team members and customers; communicating with internal project team members and customers on all aspects of data management activities performed for a study; authoring data management documents; performing user acceptance testing on data management deliverables; and facilitating and verifying data clarifications and data changes.

Want to join the Best Team of Your Life?
We’re looking for people who are excited by the potential to make a difference in the world. You need to be decisive, open to celebrating mistakes, able to communicate transparently and inclusively, and someone your team can count on. Most of all you need to be yourself!

As part of our team, your Key Accountabilities:

• Collaborate across functional groups to address technical issues impacting quality, drive forward technical initiatives within Data Management
• Provides data management guidance to internal project team members and customers
• Communicates with internal project team members and customers on all aspects of data management activities performed for a study
• Authors data management plans (DMP) and data transfer specifications (DTS)
• Performs user acceptance testing on reports and automated data checks programmed to support the data cleaning activities specified in the DMP
• Reviews, makes decisions, and acts upon output from automated data checks
• Facilitates risk assessments for mid-study changes
• Verifies data extracts against the DTS
• Provides proactive data monitoring per contractual obligations
• Facilitates and verifies data clarifications, data corrections, and external data reconciliation
• Contribute to the development and update of process improvements that reduce processing times, increase quality, mitigate operations risks, improve team performance, and meet departmental objectives and corporate objectives
• Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget
• Assists in developing and improving Standard Operating Procedures (SOPs), Working Instructions and Best Practices.

You’ll need to bring: -

• BA/BS degree in a relevant field (Medicine, Statistics, Computer Science) or equivalent work experience
• 8+ years of professional experience in the clinical trials data management field
• Strong verbal and written communication skills
• Ability to complete high quality technical documentation and to understand requirements related to system and front-end functionality, including how that impacts how and when data is saved into the database
• Demonstrate extreme attention to detail and organization in all aspects of work
• Ability to quickly learn and apply new skills, procedures and approaches.
• Demonstrated ability to meet very short deadlines & multi-task in an extremely fast-paced work environment with little direct supervision
• Proven ability to work both independently and in a team-oriented environment, providing back-up support to team members & establishing/maintaining effective work relationships with co-workers within and across functional areas
• Previously demonstrated proactive and positive approach to tasks and projects overall, as well as to the types of scheduling & process changes that are inherent in a fast-paced business
• Knowledge of CDISC standards and clinical trial systems/tools such as eCOA (ePRO, eClinRO), RTSM, EDC, CTMS, CDMS.
• Proficient in Access, Excel, and other office software technologies and applications

We would be thrilled if you bring in the below

• Knowledge of database structures or programming languages such as SAS, SQL, etc. is a plus.
• Familiarity with GCP and 21 CFR Part 11 is a plus
• Good people / team management skills (direct or indirect supervision)

Decision Making AND Influence

• Participates in special data-related projects as needed
• Assist with other departmental initiatives and projects as required
• Mentors less experience staff. Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
• Represent Clinical Data Management in client visits, audits, inspections and bid defenses as needed

We know that everyone has different wants and needs, which is why along with a highly competitive base salary we support our people and their loved ones with a variety of perks and benefits. As part of our team some of the benefits you can expect to receive are:

• Medical Insurance, Group Accidental Coverage/Insurance, Group Term Life Insurance
• Company Paid Subscription to Calm – The #1 app for mental fitness.
• Employee Referral Program – Bring the Best to Signant Health and earn a reward
• Wellness Program – Participate in challenges and earn points for rewards.
• Proof! – Signant’s Employee Recognition Program where you can accumulate points to redeem for exciting merchandise, gift cards, tickets, and more
• Burn Along – Digital fitness and wellness platform

Does this sound like something you’d like to explore? Then we’d love to hear from you!

To apply, please submit your CV and a cover letter letting us know why you think you’d be perfect for this role. We will begin reviewing submissions during the application period and will fill the vacancy as soon as a suitable candidate is identified.
Please note that Signant does not accept unsolicited resumes from Third Party vendors.
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At Signant Health, accepting difference isn’t enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.