Here at Celgene, we are seeking our next forward-thinking colleague – following a period of growth within Study Programs, we have an opportunity for a Data Scientist to work within our Medical Affairs group, focussing on Immunology & Inflammation.
Reporting into the Associate Director of Global Medical Affairs for this group, you are someone who can provide support to the Celgene Study Programs which have been coordinated by the Medical Affairs team – principally, the Celgene-sponsored non-interventional studies.
Leading the Data Management planning, you will have responsibility for study set-up and execution, as you work with both internal experts and our outsourced partners – this role is therefore ideal for those that have a proven track record (3+ years), as a Data Manager for a pharma / biotech or CRO organisation.
You will provide a key contribution in this function, performing a hybrid Data Manager / Research Scientist role – this is to ensure high quality and standardised data collection across the portfolio, which is validated in the clinical database in a timely manner and to a high standard.
As you partner with several departments in the company, you will have frequent contact with the affiliates across our WorldWide Markets – therefore, prior experience of working “above-country”, and across different cultures, is advantageous.
Splitting your day between meeting deadlines / managing priorities / multi-tasking, we offer you an environment which is well-matched to someone who can work with their own initiative whilst also being accountable to the team.
“A day in the life of” – your responsibilities will include:
1. Functional Proficiencies
- Review protocols and support CRF development in collaboration with study teams
- Demonstrate ability to analyze data, share trends/observations with team members and management around results and relevant metrics
- Lead DM study start-up and maintenance activities - CRF design/edit check specifications/external vendor specifications, CRF completion guidelines, (CCGs), coding, etc
- Lead Celgene team with User Acceptance Testing as applicable
- Lead SAE reconciliation, data review and query management
- Prepare or review the Data Management Plan and essential documentation
- Adhere to data standards and proper data validation processes
- Lead database lock or snapshot activities: inclusive of interim/final SAE reconciliation and interim/final data review
- Lead/Participate in regular team meetings and provide input when appropriate
- Core study team member and primary contact for data management
- Prepare metrics and reports required to analyze the study performance
- Provide input and assist in review/adherence to project timelines
2. Oversight of CRO and Vendors
- Provide oversight of vendor activities to ensure quality and timely deliverables
- Participate in CRO/external vendor selection
- Review Statement of Work (SOW)/contracts and data transfer specifications and agreements
- Provide CRO oversight of the data management functional activities and monitor progress and deliverables
- Ensure training on Celgene SOPs, if applicable
3. Additional Activities
- Participate in the initiatives and projects linked to the coordination and oversight of the Celgene Study Programs as needed
- Participate in writing/reviewing of functional SOPs/Working Procedures/Guidance Documents
- Ensure affiliates and departmental companion groups (Safety, PSRM, etc.) are consulted appropriately on study decisions
- Train Medical Affairs colleagues on Celgene and data management standards and processes
- Liaise with cross-functional teams to provide data management deliverables to health agencies
- Contribute to continuous improvement on the responsibilities above and promote high quality standards and audit readiness
Your background comprises…
- This role is ideal for an individual who has 3+ years’ experience as a lead Data Manager in a pharmaceutical / biopharma or CRO setting
- It is also essential to have solid working knowledge of late phase and real-world research
- You are someone who has strong working knowledge of EDC databases.
- Additional knowledge of J-Review or other reporting tool and understanding of SDTM and CDISC.
- It would also be great if you have knowledge of and interest in analytics and visualization (Tableau, Spotfire) techniques a plus.
- Working within our Immunology & Inflammation franchise, intermediate knowledge of this therapeutic area would be great but is not essential
- Knowledge of FDA/ICH guidelines and industry standard practices regarding data management
Your personality is…
- This role is ideal for a self-starter, who is proactive and can work with a sense of urgency
- Your ability to work independently would complement our existing culture
- Plans and executes own area of responsibilities through predefined standards and objectives
- Shows solid interpersonal skills and understanding of all project team functions to obtain necessary information from other project team members
Your skill-set includes…
- We are seeking for applicants to possess a Master’s degree as minimum (possessing a PhD or PharmD would be hugely advantageous but not essential)
- If you do have additional On-the-Job training, that is always preferred
- For you to be proficient in Microsoft Office MS Word, Excel and
- Strong written and oral communication skills
- Good organizational skills, ability to prioritize and multi-task and demonstrate flexibility and attention to detail