Department: Trial Data Management.
Are you passionate about Project Leadership, Data Literacy, Generating data insights from Data analytics tools, and being part of an incredible team that changes patient lives Do you have an innovative mindset to drive change in a future-ready environment and support your colleagues and stakeholders by challenging the status quo in a friendly and open-minded way If so, there is a job opportunity waiting for you as Project Data Manager. At Novo Nordisk, we will challenge you to do the best work of your life. Apply Now.
About The Department
The Trial data management department was established in Bangalore, India in September 2007 and has significantly grown. It is a young, enthusiastic, and dynamic team with varied skills and professionals from diverse backgrounds such as pharmacy, life sciences, physiotherapy, computer/information sciences, and business administration. The key objective of the department is to ensure high-quality data delivery to the stakeholders. The involvement of various groups in data management is significant in key stages of trial setup, conduct, and closeout. The Cardiovascular, Kidney & Alzheimer's Disease (CKAD) are driving our expanding portfolio within serious chronic diseases such as cardiovascular diseases, CKD, and Alzheimer's Disease and executing large outcomes trials.
The Position
The Project Data Manager (PDM) is overall responsible for the data management deliverables in a Clinical Development Project. The Project Data Manager is a leader within the DM community and represents the project's data management area both inside and outside the project. In addition, the PDM is a sparring partner to management and other project stakeholders. The Project Data Manager demonstrates subject matter expertise with in-depth knowledge and experience and extensive business understanding across the SVP area. The PDM works independently with minimal guidance and acts as a resource for colleagues with less experience. The PDM uses best practices and knowledge of internal or external business issues to improve processes. The Project Data Manager will be part of the Cardiovascular, Kidney & Alzheimer's Disease team, Trial Data Management Bangalore, and overall Novo Nordisk phase 2-4 clinical trials project responsibility is anchored in Sborg, Denmark.
- Participate and Provide input in early trial design to optimize the design, and pro-actively identify gaps, risks, and issues for upcoming trials and projects. Take accountability for end-to-end DM deliverables from data collection to SDTM. Accountable and driving the projects across Cardiovascular, Kidney & Alzheimer's Disease therapeutic area phase 2-4 clinical trials across the globe.
- Ensure data quality on the trials and timely achievement of major DM deliverables. Maintain project overview, including project-level oversight of vendor performance.
- Accountable for timely and quality DM deliverables, and alignment across trials in a project-supporting direction within the DM Project and Trial.
- Contribute and support with development of high-performance teams, and build a TDM project team. Empower the CTDMs to make decisions and set direction for their trial. Support complex issue resolution on the trial.
- The Project Data Manager is accountable for setting and supporting direction within the Data Management Project and Trial. Lead the Project DM triage and ensure collaboration with the lead CDP and lead SDTMP. Set expectations with CTDM PoC, lead CDP, and lead SDTMP about communication and status updates. Provide input to TDM strategy together with management and support the TDM strategy to action.
Qualifications
- MSc/BSc in Natural/Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science, or clinical information management or equivalent qualifications and a degree in computer science or equivalent professional experience.
- Minimum 8 years of experience in data management the majority of this within Pharma Industry or Development.
- PhD with 4-5 years relevant experience /Masters with 6-8 years relevant experience/ Bachelor with 10+ years relevant experience or equivalent knowledge through relevant practical experience.
- Therapeutic area knowledge of Cardiovascular, Kidney & Alzheimer's Disease clinical trials will be an added advantage.
- Experience in driving automation, proven fats on utilizing AI & ML for clinical trial data management will be highly preferred.
- Knowledge of industry trends, regulatory requirements, and experience in Health Authorities inspections.
- Excellent knowledge of a specific process and extensive business understanding across the SVP area. In-depth understanding of GCP and relevant regulatory requirements.
- Good project management and leadership skills. Good presentation, communication, and negotiation skills. Fluent in written and verbal English.
Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions worldwide and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees worldwide. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life-changing.
Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Deadline
17th April, 2024
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
