- Entry level
- No Education
- Salary to negotiate
- South San Francisco
The Program Clinical Data Manager is accountable for the delivery of all of the data management deliverables from clinical trials (Local Affiliate and Multi-National Trials) sponsored by Genentech US Medical Affairs. The role includes oversight of the data management work conducted by external data management vendors, irrespective of whether business model used (for instance, full outsourcing or Functional Service Provider)
This role requires the data manager to be technically competent, have excellent customer service skills and a desire to engage customers in pursuit of new business opportunities. Additionally, this individual will have proficient organizational skills and the ability to assess future resource requirements. The role also requires the data manager to be positive, engaged, innovative and professional in their approach to their work.
The accountabilities of the Clinical Data Manager include, but are not limited to:
Oversight of the work of the data management work conducted by the data management vendors
Supports data management vendors working in the FSP model in gaining access to and understanding Roche Genentech SOPs and business process documentation.
Conducting SAE reconciliation for the studies under their responsibility and working with members of the SMT and US Drug Safety to resolve issues
Ensure the Medical Teams and SMTs have prompt, complete and clear status updates on the status of the data management deliverables for sponsored studies
Provides data management input to trial design and protocol development
Delivery of the Data Management Plan and associated components (including Biosample Management Plan, Data Validation Specifications, Data Quality Components and Data Review Plan)
Seeks and includes input from SMT members
Working with the data management vendor to quality assure the quality and quality control (QC) of the vendor deliverables. This incorporates UAT of the clinical database
Proactively and collaboratively works with the Data Solutions colleagues on the planned timing of the raw data and SDTM compliant data from the vendor database
In collaboration with Data Solutions, supports delivery of tools and listings to support the Medical Teams and the SMTs in surfacing data (Patient Profiles, Data Listings etc). The data manager may be required to generate a simple listing or report using a tool such as SAS, RAVE or Spotfire
Collaborates closely with Data Solutions colleagues on the timing of data delivery for PBRERs and DSURs
Ensuring the archiving of all data management deliverables in eTMF in a timely basis.
Deliver the data management contributions on sponsored studies for key initiatives such as RBM (Risk Based Monitoring)
Support the hiring of permanent data management staff and on-site consultants, as required.
Assists in on-boarding, coaching or mentoring new or less experienced team members, including on-site consultants.
Making an engaged contribution to delivery of the Medical Team goals.
Contribution to the DATA Group Meetings and making an engaged contribution towards the delivery of DATA Group Functional goals.
Creation of Annual Personal Development Plan and commitment to ensuring it’s completion.
Being compliant with all applicable training, SOPs and Policies impacting the work of Genentech colleagues, in general, and USMA and Data Management, in particular.
When required, updating data core business management systems (eg Plansource, CTMS, budget management systems) with quality data, on time. Supporting the Data Management Therapeutic Area Head with data issues identified in i2V.
Timely submission of business expenses into the core expense management systems (Concur) for review.
Working with Administrative Associate colleagues, as required, to manage personal business travel.
Working collaboratively with Roche-Genentech data management colleagues in other divisions, including gRed, pRed, PD and PDMA.
When required, contributing to one or more major cross-functional (within EG) or cross-USMA initiatives.
When required, deputize for the Data Management Head at Senior Meetings such as the DATA LT, Evidence Generation Leadership Team or MLT.
As required, give presentations at senior management fora on the status of key projects or initiatives.
Work collaboratively with Program Data Managers in the other therapeutic area (Oncology or non-Oncology) and with the Programming Team in Data Solutions.
Work collaboratively with
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.