The Opportunity
The Therapeutic Data Manager Lead will contribute to the company's Clinical Data Management organizational and Therapeutic Area Data strategies, lead and deliver on complex projects, and interact with external partners. Responsible for global and broad organizational high impact deliverables.
Responsibilities will include:
Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies and projects.
Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones.
Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models.
Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data.
Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results.
Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis.
Who You Are:
Required:
BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience.
7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required).
Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity.
Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing.
Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques.
Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.
Preferred:
Medical affairs experience (Phase IIIB - IV trials experience)
Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI).
Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau).
Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming.
BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions.
Location / Travel
This is an onsite role and must be on campus a minimum of 3 days per week.
Up to 10% travel for conferences, investigator meetings, etc.
The expected salary range for this position based on the primary location of South San Francisco, California is $140,900 - 261,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Relocation benefits are not available for this posting.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .
#J-18808-Ljbffr...could have on the food service industry. There's a seat at our table for you... 2nd Shift Warehouse Package Handler Distribution Center Address: 225 Solar Dr., Imperial, PA Pay: Starting at $20.55/hour ~ Plus, earn two pay raises in your first year...
...Your Contribution As a Manager of Logistics reporting to the Plant Manager- Murfreesboro, you will be a key member of the Plant Leadership Team, serving as a true business partner to the Plant Manager. The overall objective is to develop short-term and long-term...
...Description Job Description Active Licensed Practical Nurse (LPN) license and minimum 1+ years Licensed Practical Nurse (LPN)... ...or Licensed Vocational Nurse (LVN) credentials is sought for a contract assignment supporting K-12 students in a school district setting...
...leader in blood health dedicated to improving patient outcomes through precision medicine and transfusion science. As a Medical Laboratory Scientist, youll perform critical immunohematology testing and ensure the safe and accurate provision of blood products for transfusion...
...A remote survey panel organization is seeking a Data Entry Clerk for an entry-level position. This role allows you to work from home with maximum flexibility and earn extra income. Ideal candidates are self-motivated individuals who enjoy data entry tasks and can follow...