Project team responsibilities

After a pharmaceutical or biotechnology company, commonly referred to as the sponsor, has decided to use CROs to support some or all of the nonclinical research effort in a drug development program, management or the project team responsible for the development of the drug candidate assigns individuals to identify and select the appropriate CROs. The steps in a selection process should include, but are not be limited to ... 

Review Follow-up Verification In addition to someone tracking the follow-up through progress reports, responsibility should be assigned to verify that any process changes were ac tuaUy made in the field. This verification can be done by a review team as part of a process pre-start-up review. It could also be part of the project team management responsibihty or assigned to a particular functional (i.e., safety and loss prevention) representative. The closure of the review process is complete once implementation is verified. 

You should consider obtaining internal and external quality assurance reviews of the study (to ferret out errors in modeling, data, etc.). Independent peer reviews of the QRA results can be helpful by presenting alternate viewpoints, and you should include outside experts (either consultants or personnel from another plant) on the QRA review panel. You should also set up a mechanism wherein disputes between QRA team members (e.g., technical arguments about safety issues) can be voiced and reconciled. All of these factors play an essential role in producing a defendable, high-quality QRA. Once the QRA is complete, you must formally document your response to the project team s final report and any recommendations it contains. 

Establishing overall and specific organizational roles and responsibilities of different functions and disciplines by defining individual roles, responsibilities, accountabilities, and interfaces in the project team with matrix personnel and organizations, and between contractors and subcontractors. 

The project team organization. This will help to identify key individuals and alternates, roles and responsibilities, and other on-site and off-site resources. 

The organizational chart further identifies key positions in the project team, including the project director, project manager, site safety and health officer (SSHO), site supervisor, emergency response coordinator, site security, and other specialized positions. 

The following sections describe roles and responsibilities that may be included in a project team. 

Security issues involving access controls are typically line management responsibilities. However, it is not unheard of to have the SSHO in charge of site access or other security-related matters. However, if the field team leader or site supervisors are in charge of access issues or other security matters, they should always strive for SSHO participation. The nature of a project may warrant assigning a member of the site security staff to the project team. Key duties of the security officer may include the following ... 

To be successful, a team selected from different groups within the project team should participate in the preparation and review of these plans. In addition, a schedule of the review and approval process for these plans needs to be established, accepted by all reviewers, and distributed before release of the first draft. Reviewers should meet an established schedule for review and submission of comments. A distinction between review and approval authority should be determined. The review process determines if all of the required elements are identified. This review can take considerable time, depending on the complexity of the project. The approval process is important when all comments are incorporated. The key responsible persons associated with the project should accept and approve the changes to the document. 

HAZWOPER specifically requires that project personnel and responsibilities be well defined. Refer to our discussion on project team organization in Chapter 3. 

The standard requires that if a project management approach is used, a project manager and project team be assigned, that appropriate resources be allocated, and any special responsibilities and organizational interfaces be defined. 

Hybrid approaches are generally more difficult to manage as the relationships and division of responsibilities between the PSM project teams and other management varies from element to element. This can lead to confusion within both the PSM teams and among other managers, which can result in misunderstandings and wasted work. 

TQM calls on project teams to analyze business processes in terms of customer satisfaction, and begins with an understanding of who the customers are and who is responsible for meeting their expectations. In relatively simple processes (such as the electronic mail example), the customer-supplier relationship is fairly clearcut. In more complex processes that affect many people in different ways, there may be multiple customer and supplier categories, each requiring its own analysis. TQM untangles these processes by identifying the subprocesses, activities, and customer-supplier relationships they comprise. 

If you selected TQM techniques to address this gap, you would first assemble a TQM project team. (See Section 6.2 for more discussion of forming and managing teams.) Such a team would include representatives of the functional group that "owns" the process (that is, the people responsible for its operation), as well as of other groups who are the process s customers and suppliers, for example ... 

Once the order in which you plan to develop management processes, programs, and elements has been established, you must assign responsibilities for the work. These will be shared between the project team and local managers and staff. Generally, small development teams will be established to work on particular processes, programs, and elements. Ideally each team should include the following ... 

The number of people involved in a project varies with its size and scope. Not every project has a different person responsible for each task. To make the best use of your resources when deciding who is responsible for a portion of your project, broaden your point of view to include subcontractors and service departments as well as members of the project team. 

Operating Basis As the SIS engineering design nears completion, the resources and skills of plant operations should be considered. At some point, the SIS is turned over to operations and maintenance personnel, who must be trained on the new SIS and on their responsibilities. Consequently, thought should be given to the content and depth of the information that must be communicated to various personnel. This is especially important as the responsibility for the SIS transitions from the project team to operations and maintenance control. 

Although project teams, once integrated and functioning with clear roles and responsibilities, perform better, this edge can be quickly lost... 

Daily project meeting At this time, each team member updates progress and expresses problems to which the project team needs to react quickly. The problems can be requirement ambiguities, technical difficulties, delays in task completions, and so on. Also, the project manager and the technical lead have to step out and take responsibility for helping the project team to solve these problems. 

The project team is responsible for completing this assessment. 

Controlling an integration program can be a Herculean task. With projects (and sub-projects) running in parallel and countless individual actions documented with concrete end products, responsibilities and deadlines, a high level of complexity is guaranteed. In addition, individual project teams often work at different locations in different countries. 

If the laboratory does not provide the sampling containers, a member of the project team should identify the vendors and purchase the containers that meet the SAP requirements. Obtaining proper field sampling equipment and supplies is usually a responsibility of the sampling crew. This may constitute an extensive list ranging from bailers and hand augers to such mundane but vital items as pens and shipping tape. 

It is the responsibility of the R D Manager to ensure that the people who are nominated to work on project teams fulfil these criteria and, if there is any doubt, deliver coaching or training on these aspects. 

The Project Team Manager and members having been assigned to the project, their first task is to carry out a complete definition of the project. The team will know the overall goal of the project but its purpose and objectives will need to be clarified and redefined in more specific terms of defiverables, assumptions and constraints. Project definition enables all the stakeholders, both internal and external, to understand and agree upon the goals, responsibilities, assumptions and success criteria to be used. The planning of the project and the allocation of resources should only start once this has been done. 

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