Work as Senior Clinical Data Manager at United Health Group

At UnitedHealth Group, our mission is to help people live healthier lives. To achieve this goal, we are focused on building a modern, adaptable, innovative and inclusive system of health care services.
Our scale and potential to improve health makes us one of the most visible stewards of America’s vast health care system. Entrusted with both important resources and responsibilities, we are involved on a daily basis in decision-making that has life-changing consequences for millions of Americans.

Post: Senior Clinical Data Manager - 328489

Job Description:
Assumes overall responsibility for the successful execution of the data management projects assigned to them. Lead DM with minimal supervision for several midsize to complex projects/partnerships.
- Writes, updates/reviews and approves all required trial data management documentation, documents and presents CRF completion guidelines at investigator meetings.
- Performs any data management activities related to projects, as needed.
- Provides leadership and may supervise/train Data Management staff assigned to work on their projects, including Clinical Data Coordinators and other Data Mangers, supports training of project staff.
- Monitors the progress of all data management activities for the project to ensure that project timelines are met. Directs activities associated with data integration and data.
- Monitors the quality and coordinates all data management QC activities for the project. Establishes and coordinates the timely completion of the database lock procedures. Understands and follows the process if the database needs to be unlocked
- Monitors the data management process for the project to ensure that work is proceeding in an efficient manner.
- Establishes timelines to perform an audit and oversees activities of audit team. Ensures adequate preparation for internal and external database and data management audits, can respond knowledgeably and confidently to issues or questions that arise during audits
- Serves as Data Management contact with sponsor managing their expectations, noting and responding to out-of-scope work. Liaise with clients on limited basis and produce trial progress reports
- Some business development work may be required, such as input to proposals and client presentations.
- Remain informed of new developments in data management that are relevant to the industry. Participate in the development of Standard Operating Procedures (SOPs) and guidelines
- Provide feedback to team members and supervisors (if applicable) on individual performance and contributions to the overall team effort in a constructive manner
- Some line management activities may be required with the ability to guide and counsel direct reports/mentees on their career development.
- Work effectively with international peers and sponsors, as needed.
- Assist in directing global data management projects to ensure the seamless provision of services
- Have thorough understanding of data management budgets and can communicate out of scope requests to the project manager.

Desired Profile:
- Undergraduate degree or equivalent experience. BA / BS Degree in life sciences, or an equivalent combination of education and work experience.
- Extensive experience in leading data management activities for multiple mid size to large/complex studies. Previous team leadership experience or strong leadership skills.
- Thorough knowledge of applicable regulatory rules and guidelines; e.g. ICH, GCP.
- Demonstrated proficiency in the data management process.
- Excellent interpersonal and communication skills (written and verbal) together with presentation skills
- Strong attention to detail and problem solving skills. Ability to work in a fast-paced, teamoriented environment.
- Proficient in the use of the clinical data management systems used at i3 Statprobe, understands the structure of an electronic medical dictionary and how auto encoding works
- Possesses a positive attitude and works well within onsite teams and off site teams
- Basic Programming Knowledge (for example SQL)

Additional Information:
Exp: 1-2 yrs
Location: Mumbai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR