Lead Clinical Data Manager

Job description

Job Description

Lead Clinical Data Manager, Novartis, Prague, Czech Republic

Welcome to the future of medicine.
Be part of a rapidly growing, diverse and high caliber team of passionate people who strive to make a difference. Join the Novartis team in Prague and enjoy our inspiring environment. We offer a comprehensive compensation package, a wealth of opportunities for career development and an undeniably friendly culture.

Job Summary:

Novartis is currently searching for a Lead Clinical Data Manager to join the PLS department.

Job Purpose:

The purpose of the Lead Clinical Data Manager role is to ensure quality and timely clinical data delivery for multiple local studies including Phase IIIB/IV using appropriate application of data standards, monitor vendor progress, and perform quality assurance review of key clinical data management (CDM) deliverables.

Key Responsibilities:

- Serve as Lead Data Manager for multiple projects/trials from multiple franchises and providing professional Data Management input to Clinical Trial Teams (CTTs). - Responsible for ensuring consistency of protocols, project CRFs, clinical databases for all trials within assigned projects and provide technical feedback to CPOs as needed.
- Provide CDM input to study protocols and Study Specification Worksheets (SSW) for CPO proposal requests; provide input/create quotes.
- Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings, and Validation and Analysis Plans (VAPs) as appropriate.
- Ensure complete and consistent medical term coding using appropriate standard dictionaries; ensure consistency of serious adverse event data across clinical and drug safety databases.
- Monitor clinical data quality and progress of trials with CTS; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable.
- Proactively identify project threats and resolve issues with clinical trial teams; escalate to CTS management if necessary and appropriate.
- Ensure up-to-date and accurate tracking of report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases.
- Ensure timely completion of data management archiving; as necessary; respond to Health Authority/FDA/audit requests pertaining to project-specific data management issues.
- Provide input, review, and maintenance of local working practices and standards. - Participate in the development of a Data Management organization through his/her leadership role within the DM Group for CTS.
- Participate in clinical & non-clinical special projects. May assist in hiring, coaching, training, and mentoring of other Data Management staff.

About us:

Novartis Global Service Center (NGSC) in Prague:
The Center, one of 5 around the world, delivers a broad variety of services to the Novartis worldwide. We have highly qualified teams in areas such as scientific and commercial services (known as Product Lifecycle Services), IT, Human Resources, Financial Reporting & Accounting, Procurement, Real Estate and Facility Services, Legal & Compliance, Finance and Communications.

Here’s some of the reasons we think you should join us:
• A job with a purpose. At Novartis, we all contribute to our mission to discover new ways to improve and extend people’s lives.
• A wealth of opportunities for career progression and working with best-in-class professionals.
• A diverse team that reflects the rich diversity of our markets. Over 55 nationalities speaking with 30+ languages, all generations, and more than 44% of female.
• Our modern and newly designed workplace is a pleasant place that reflects the need for flexible ways of working in order to bring new ideas to life.
• We live by our values; we cherish not only what we do but also how we do it. .
• Diversity & Inclusion mind-set. We aspire to move beyond stereotypes and bias to bring differences together, so we can see the world through the eyes of our patients and customers.

Our comprehensive compensation package includes:
• Competitive salary;
• Annual performance-based bonus;
• Employee recognition scheme;
• A benefits scheme above local legislation standards including pension and risk-life insurance, benefit package for health, education, culture and sport activities;
• Healthcare program that offers easy access to comprehensive health care;
• Variety of medical check-ups or consultations on-site;
• An Employee Assistance Program;
• 25 days annual leave, 4 days paid sick leave and Christmas holiday;
• Public transport allowance;
• Flexible working arrangements including Home Office;
• Support for a healthy lifestyle through the daily offering of fruit & vegetables.

We are looking forward to talking to you and sharing more about our broad range of opportunities.
Position Title

Lead Clinical Data Manager

Desired profile

Minimum requirements

The ideal candidate will have:

- University or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree.
- Fluent English (oral and written)
- Ideally 4 or more years’ experience in drug development, with at least 3 years in Data Management activities.
- Experience in managing outsourced studies or working for a CRO. -
- Understanding SAS output and introductory level skills with SAS.
- Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding.
- Project team leadership experience; good organizational and project management skills.
- Ability to work independently, demonstrating initiative and flexibility.
- Attention to detail and quality focused.
- Good interpersonal and communication skills and ability to operate effectively in an international environment.
- Good negotiation skills. Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners.

Novartis is an equal opportunities employer and welcome applications from all suitably qualified persons.
Job Type

Full Time
Country

Czech Republic
Work Location

Prague
Functional Area

Research & Development
Division

NBS
Business Unit

PLS NBS
Employment Type

Regular
Company/Legal Entity

NOV CZE