Project Management Methodology

In a Functional Service Provider (FSP) model, a company has continuous interaction with the team, providing support, training, supervision, timeline management, budget management, and mentoring. They also place teams at the clients’ site. Each team will typically have a Project Manager or Lead, and depending on the size of the team could have both. So how does a successful company, using an FSP model, deploy effective Project Management?

The Project Manager (PM) reports to an Executive Manager and is the direct contact with the client. The key is that you place professional, experienced, and competent managers in the chain of command who take responsibility for all aspects of the work from resource allocation, to timeline management, budgeting, and quality control.

The characteristics of a successful FSP model include weekly meetings among internal team members, who report their status to the PM. The PM then hosts weekly calls with the client to discuss high-level issues regarding staffing, timelines, budget, and any other project issues that may arise. The team can communicate daily with their counterparts at the client if required.

This successful FSP model along with Project Management allows DataCeutics’ PMs to manage employees by providing supervision, quality checks and aligning the tasks they need to complete with our employees’ individual strengths, and to ensure on-time delivery as well as staying within the budget.

Most of DataCeutics’ teams include Senior Programmers, Lead Programmers, and a PM. The PM manages the day-to-day workload of the staff. A technical or programming issue is escalated to the PM. At that point, the PM will assign it to one or more Lead Programmers. Additionally, technical or programming issues are reviewed at the weekly team meeting. If an issue has not been resolved, then a Principal Consultant (who are the most senior employees of DataCeutics) is asked to step in and help resolve the issue. Lead Programmers function as backup for the PM by managing specific tasks and deadlines for a subset of the team. They also function as Data/Statistical SAS Programmers. Leads are full-time on the team.

The value these separate functions bring to the client is manifold. A PM will manage all aspects of a project, from resource allocation, to timelines, budgets, and quality. However, hour-by-hour leadership on a smaller scale is effectively provided by our Lead Programmers, whose key contributions include managing specific tasks on a subset of the project. The PM interfaces with both Senior Management and Project Management at the client, keeping them appraised of all aspects of the project at a high level. They also will escalate any issues. The Line Manager deals with the day-to-day issues and planning for the team.

The other roles involved in our FSP include the role of the Senior Vice President of Professional Services and the Executive Director of Professional Services. One of these professionals would be assigned executive-level responsibilities over the project.

The Leads and PMs are technically trained, have at least 10 years of pharmaceutical experience, and have been trained in CDISC. They function as part of the Statistical SAS Programming team, performing all the same tasks as any programmer – creating TLFs, datasets, etc.

The PM and Lead can help to improve the process by drawing upon past engagements with clients and using the knowledge found. The PM regularly produces documentation to track issues and concerns that can be reviewed and used for improvement in quality and efficiency. The PM can also draw upon the knowledge of the Senior Management at DataCeutics to help improve the process. The Data/Statistical Programmers and Biostatisticians meet with the PM and Lead to discuss issues they have which also may affect other staff so that the resolution can be introduced to the team and help with efficiencies and quality.