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.
At Level E5, the individual will be delivering on all of the E4 accountabilities and, in addition, will have a proven history of influencing clinical data management outside of USMA, specifically collaborating with colleagues in PD and/or gRed and/or PDMA on projects of mutual benefit.
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 isting 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 colleagues in other USMA Medical Units (for instance, Knowledge Enhancement, US Drug Safety, RWD)
Support Data Management Head in ongoing resource estimations (headcount and spend), especially Annual resource estimations.
Staying abreast of internal and external developments (scientific, clinical, medical, commercial, competitive, legal, regulatory et al) which may impact the portfolio of data management work.
2. Key Competencies / Experiences
The competencies/experiences of the Clinical Data Manager include, but are not limited to:
At E5, the data manager will have at least 12 years’ experience of working in the pharmaceutical, clinical research or medical device industries
At E5, the data manager will have at least 8 years’ experience of hands on clinical data management (database creation, study conduct and closeout etc)
Excellent problem solving and analytical skills.
Excellent presentation skills – both technical and non-technical presentations.
Excellent verbal and written communication skills.
Excellent collaborative and team-working skills, as demonstrated by working collaboratively with colleagues in other technical disciplines or at other geographical locations.
Proven competence of development of software under a Software Development Lifecycle (SDLC).
3. Compliance, Audit and Quality Assurance
The Clinical Data Manager will have particular responsibility for:
Ensuring personal compliance to all applicable Roche SOPs, Policies and Compliance documentation.
Keeping personal Training and training records (eg LSO) up to date.
Keeping Development Plan updated.
Delivering programming components of internal audits (for instance, PDQA) and external audits (includes FDA and EMA Audits)
Managing the level of Quality Control (QC) conducted by external vendors (specifically, FSP vendors) and managing QA of the programming deliverables and QC documentation, once it arrives into Evidence Generation.
4. External Organisations
The Clinical Data Manager will:
Be willing to represent USMA DATA Group and Evidence Generation, and give presentations/chair meetings as necessary, at key external meetings such as DIA, ASCO, SCDM etc
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