Our client is looking to replace a project manager currently working on an ongoing project (started Q3 2019). Below is information about the project scope and profile(s) needed.
The profile described further below is two folded (project management and technical). It can be covered by a single person or 2 persons. The person performing project management activities must be on site (Paris Area). The person overseeing technical activities (either perform or coordinates) can be located remotely.
If 2 persons are proposed, Our client may decide to go ahead with one but not the other, based on outcome of interviews.
The duration of the project is 1 year (expected go-live date is December 2020).
Project management is estimated at 40-60% FTE while technical related activities are estimated at 20-40% FTE
Our client’s Request: IT Project Manager and Technical coordination
Project: XBiom 3.2 upgrade
Description of the system to upgrade:
- XBiom is a platform hosting 2 applications, acting as the “Clinical and non-clinical Data Warehouse”, allowing to centrally store all of Our client’s clinical and non-clinical data (trial lifecycle as well as submissions).
- Clinical application is known as ‘CTDC’ while non-clinical application is known as ‘iSEND’
- Applications provide workflows allowing to manage study and submission lifecycles.
- Applications also allow to manage standard models such as SDTM+ and SEND+ (based on industry ones).
- CTDC is also interfaced with SAS.
Description of project:
Upgrade to latest release of XBiom, which shall bring:
- bugs resolution
- Main ones are:
- GDPR requirements
- Allow to load huge volume of data
- Allow to load images
- Enable SAS based interface for non-clinical + revise and enhance currently existing interface
- Enable an interface with CTDC (clinical part) and MDM (Master Data Management using Informatica’s solution)
- Allow to share data with partners (outbound data posting)
- renewal of technical stack
System technical environment (XBiom):
- Windows 2016 (2 servers)
- Linux RedHat 7.6 (4 servers)
- IIS and tomcat used
- Hadoop to stored all files loaded in the system (3 nodes + 1 serving as the backup node) – Cloudera distribution used for Hadoop
- Oracle 12.2 for DB (storing everything except clinical and non-clinical data)
- sFTP server
- System available from LAN as well as from internet (reverse proxied URLs)
- PointCross – solution provider, based in India
- 2nd India based partner:
- Performs SAS-XBiom interfaces development
- Performs platform Validation (in GxP sense)
- Our client’s MDM team
- Performs CTDC-MDM interface, in collaboration with PointCross
- Business Project Manager
- IT project Director (role #1 to assume)
- Our client’s project technical expert and coordinator (role #2 to assume)
- English fluent (speaking and writing), for both the project management profile and technical coordination (if 2 persons would be covering the 2 needs).
- Project management – minimum 5 years of experience with experience working on Biometry topics, more precisely clinical trials and their lifecycle
- follows and revises the project planning,
- identifies risks and provides mitigation
- prepares and leads steering committees
- coordinates activities between main stakeholders (software provider, development and validation contractors, business customers, hosting Company)
- in collaboration with Quality Assurance and validation team, ensures all documentation respects Quality standards, policies and procedures.
- in collaboration with Quality Assurance and validation team, ensures delivered solutions are compliant with relevant legal and regulatory requirements.
- Good level of technical understanding allowing to globally understand what needs to be done, so to be able to act as the liaison between our hosting Company, Tata Consulting Services (TCS) and external partners.
Below examples of activities to perform.
- Contribute to the debug of any technical problem for which issue resides on Our client side *
- Request to Create, Update, modify AD accounts (generic and service accounts) and verify
- Request to Create, Update, modify DNS entries and verify *
- Request to Setup reverse proxy and verify*
- Create SSL certificates*
- VPNSSL issues (tool used for remote access for partners) and verify
- Request to configure VPNSSL to allow one to connect to a new environment, new resource*
- Request to open ports and verify correctly opened *
- Revise sizing of servers when needed => particularly the case with disk space on OS related drive and mounts *
- Request to Update IAM (Our client’s Identify and Access Management) for new profiles and verify
- Migration activities
- write MQ protocol
- revise MQ original script
- revise MQ executed script*
- work with SAS developers to ensure they plan correctly the migration of SAS data
- Setup of XBiom reporting schema and creation of all views*
- Request to setup sFTP for XBiom * and verify
- Request to setup NetworkShare for XBiom* and verify
- Request to setup backup via $U* and verify
- Coordinate backup to be taken before any installs *
- Extract of production data and setup of rsync* (part of data migration)
Most of the above are dealt, partly or fully, by creating Service Now tickets (Our client’s ticketing tool) and assign them to TCS
* means to be done for each environment – Test, Qual, Prod