Packages
Work Package 1
Project Management and Coordination
- Involves Partners CAU and ZYMX
This Work Package (WP) shall ensure a successful management and coordination of the ALPHA-MAN project as well as precise and on time reporting to the EC. Management of the consortium on different levels will ensure solidarity and compliance with the project timetable, allow decision-making for the benefit of the whole project and optimize the cross talk within the partners. Communication between partners will occur on day to day-to-day basis by e-mail connections and phone conferences (Video or Skype).
Description of work:
In general, all partners are involved in the task of management and coordination of their own working packages. However, defined management teams on different levels will guarantee a smooth course and the progress of the project. The duties and activities of the different management teams are outlined below:
Work Package leader: The WP Leaders will be responsible for the work that will be carried out, within their own WP. They have to ensure that the required work within their WP is done and reported in an appropriate way by their participants. Problems within the WP will be addressed by WP leader. However, major problems, that cannot be solved on this level, will be referred to the Project Management team and together they will tackle the problems and solve the issues. WP Leaders will also meet at full consortium meetings. WP leaders are responsible for the quality and on time delivery of progress reports that have to be prepared by the WP participants. WP leaders have to prepare the financial reports of their own WP. When interaction within WP is required, the WP leaders have to coordinate this interaction to allow an optimal work flow within WP.
The Clinical Trial and Industrial & Innovation Management Board:
Within ALPHA-MAN, complex clinical trials are performed that generate a great amount of clinical data that have to be analysed and managed. To ensure a smooth course of the clinical trials and proper data management and analyses, a Clinical Trial (CTB) and Industrial & Innovation Management Board (IIMB) will be defined. The CTB will be represented by all clinical partners and will help all clinicians to manage and organize their clinical trials as well as possible. At regular Board meetings the CTB will discuss clinical issues e.g which patients are suitable for the trials and about the outcome of the initial trials (Phase I-II) and use of the right dose and interval for injections. The IIMB will consist of all industrial partners. As the progress of the clinical trials heavily depends on the fast and proper analyses of all clincial parameters collected during the trials a concerted action of all partners involved in this duty is required. Internal meetings of the IIMB and regular information exchanges will help to increase the industrial interactions, as well as to coordinate activities towards a fast and efficient analysis of all clincial data collected.
Project Management Team:
The Project managemtn Team (PMT) consists of four members represented by partner 1 and 2 and represents an interface between the WP leader, the PCC and the Co-ordinator and the EC (on level of the local EU officer). The PMT is responsible for the i) design and management of the project, ii) overall scheme of the project, iii) definition of the WP and timelines and iv) coordination and collaborations between research groups and information flow between research groupsor the EC and publicity. The PMT is in charge of organizing the ALPHA-MAN meetings and will manage publication and intellectual property issues. On the basis of the progress reports and ALPHA-MAN meetings the PMT can follow the progress of the project easily, identify major bottlenecks and find solutions. When necessary, the project plan can be adapted to ensure the delivery of the project results as agreed with the EC. However, major adaptations have to be approved by the PCC. The progress reports of the WP leader will also form the basis for the annual reports, that are delievered to the EU by the coordinator/PMT. Face to face meetings of the PMT will be done regularly, one day before full consortium meetings and if required in between.
The Project Coordination Committee (PCC):
The PCC represents all partners. Therefore each Partner will nominate one representative to the PCC who has the authorisation to discuss, negotiate and decide on actions proposed by the Co-ordinator and the PMT. The PCC acts as the decision making body for the ALPHA-MAN consortium and will discuss and accept recommendations made by the representative within the frame of its responsibilities. Meetings of the PCC will be held on invitation of the Co-ordinator at least once a year. There, the PCC shall consider, receive and approve the accounts for the past (financial) year, approve the budget and Implementation Plan for the next (financial) year and decide on changes in work shares as well as acceptance of new parties or withdrawals or exclusion of parties. The first meeting of the PCC (Kick-off Meeting of the project) will take place at the latest one month after the Co-ordinator has signed the Contract.
The Co-ordinator represented by partner 1 will be the contact point between the European Commission and the Consortium. After authorisation by all Parties who have signed the Contract forms and a Consortium Agreement, the Co-ordinator will sign the contract. He will have full responsibility for fulfilling the obligations as described in the EU contract, as well as for reporting and accounting to the EC. Together with the PMT he is responsible for day-to-day project management of the ALPHA-MAN project.