SOP PM-02 FAST project management v1-signed

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CONFIDENTIAL Effective Date: 27 February 2015

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Synergy Quality Management System (QMS)

Title

F.A.S.T. Project Management

Standard Operating Procedure

Document #: SOP-PM-02

Supersedes:

NA

Effective Date:

27 February 2015

DO NOT USE THIS SOP IN PRINTED FORM WITHOUT FIRST CHECKING IT IS THE LATEST VERSION

Current versions of all Synergy SOPs are available online. If you are reading this document in printed form, please check that the version number and date match the most recent version on the SOP List: https://www.projecis.com/Project/1100/File?folder=1543

Contents

1. Purpose .................................................................................................................................. 1 2. Scope ..................................................................................................................................... 1 3. Definitions and Abbreviations .................................................................................................. 1 4. Procedures ............................................................................................................................. 2

4.1. Focus ............................................................................................................................... 2 4.2. [Account]ability ................................................................................................................. 3 4.3. Simplicity .......................................................................................................................... 3 4.4. Transparency ................................................................................................................... 4

5. Appendices ............................................................................................................................. 5 6. Reference Documents ............................................................................................................ 5

1. Purpose

1.1. To establish the general principles and approaches to project management at Synergy.

1.2. To make sure all Synergy’s projects are executed in the same speedy and cost effective manner to ensure the positively outrageous customer service and satisfaction.

1.3. To establish a consistent minimum set of project metrics and milestones for effective high-level project tracking and control.

1.4. To establish the methodological basis for Synergy’s positioning as Russia’s fastest CRO.

2. Scope

Applies to all Synergy projects.

3. Definitions and Abbreviations

F.A.S.T. Project management at Synergy means the following:

Focus is about the WHAT, what are the project goals and objectives, and what do the finished product, i.e. the result and project success look like for Sponsor.

https://www.projecis.com/Project/1100/File?folder=1543

F.A.S.T. Project management Doc No. SOP-PM-02


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[Account]ability is about the WHO and WHEN, who of the Project team is doing the work, when it should be done, who is accountable and how Project manager (PM) holds them accountable. If we are accountable, we are able.

Simplicity is about the HOW, what is the best solution, how we are planning to deliver success. Is our solution simple or have we over complicated it. The simpler, the better. The simpler, the faster. The simpler, the cheaper for Sponsor.

Transparency is about QUALITY, how good and how far a project has come and what else Project team can do in order to meet Sponsor quality requirements and expectations. It’s also about our honesty with Sponsor and our progress and capability.

Projecis (PJ) – Synergy’s cloud-based project management system.

Roadmap (RM) – Synergy’s cloud-based project tracking system.

Day – business day.

4. Procedures

Roles Action Timing

4.1. Focus

Two of the key reasons for project failure are either doing the wrong job, or doing a poor job. Focus is all about ensuring that Project team is doing the right job, which will increase the probability of project success.

To do the right job, Project manager (PM) must have a clear definition of what Sponsor’s goals are, what project success looks like, as this will help understand what exactly Project team needs to do in order to achieve those goals.

When it comes to Focus PM must make sure that Sponsor and Project team don’t end up focusing on too many things either, because when everything is a priority, nothing is a priority.

The better our Focus, the easier it will be able to communicate to Project team and help ensure that Synergy is doing the right job for Sponsor.

4.1.1. PM Use the following tips to improve your focus:

1. Keep project goals and targets to a minimum, between 3-5 works best.

2. Review project goals and targets, make sure they are clear, simply explained and well understood.

3. Review the solution, approach or process in detail to ensure whether it will lead to the desired results if successfully executed.

4. Get the solution, reviewed by a third party not involved in the project such as line manager or QA and ask them to check that the focus is right.

5. Communicate clearly, simply and often to the Project team to ensure that everyone understands the goals and they everyone is aligned.

4.1.2. PM Focus on upcoming project milestones in advance to make sure all tasks are duly performed by Project team to achieve the milestone in time. Track task and to-do progress in PJ.

See Appendix I for basic project milestones and metrics.

Weekly



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4.1.3. PM Make sure all milestones are entered into RM. 5 days after Authorization

4.2. [Account]ability

Things regularly fail because it wasn’t clear who was accountable for doing the work. In business we find that a crucial task gets left undone because it wasn’t clear to someone that it was their job, their responsibility.

PM must clearly define who of the Project team is doing what and when, and what expectations of them in that role are, and PM need to ensure that this has been clearly communicated to every Project team member, and every task and to-do item in PJ is assigned to particular Owner.

If we are accountable, we are able. Account-ability means the ability!

4.2.1. PM Assign accountability to the lowest level possible, each and every task, to-do item and ticket in PJ must have responsible person.

Empower Project team members. They now have an area that is clearly within their responsibility, they can take ownership and pride in the results that they generate.

4.2.2. PM It all depends how you go about implementing it. When you first start to measure something you find that it doesn’t usually meet your expectations.

But this is just a bedding-in phase, and you should be clear with Project team that we are using this period to learn where you need to provide support and assistance.

4.2.3. PM As a leader, don’t be afraid to hold people accountable. However, when you do this, you must ensure that you provide them with the right tools, training and levels of authority to be successful.

It is also good to remind them, that whilst they are accountable for a small part, you are accountable for the overall project success, so you share a common interest in them being successful.

4.2.4. PM Track timely execution of tasks, to-do items and tickets in PJ according to the Appendix I - Project status metrics and milestones.

Provide timely necessary assistance and training to the underperforming team members.

See Appendix I – column “Check”

4.3. Simplicity

People have a strong tendency to over complicate things, especially experts. It’s almost as if they need to show their expertise at every opportunity, or they believe complex problems must have complex solutions, and then we start by looking for those complex solutions.

At Synergy we must focus on looking for the simplest solution – and by simple we don’t necessarily mean easy (that said, it might be the easiest solution available and still be complex).

Simple solutions are usually harder to find than complex solutions. So when we find our first solution, we need to ask ourselves whether it could be simpler. If so, we need to continue looking. Usually, the first solutions we find are often complex.



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The simpler the solution, the easier it will be to explain, the likelier that the team will understand it, and the higher the probability they will be able to implement it.

We can’t implement what we don’t understand!

4.3.1. PM Find and avoid unnecessary complexities. What you will probably hear is “we have always done it that way. That’s our standard process.”

That is a clear indication of an area that needs to be investigated. One of the reasons for the low R&D productivity is that practically every Sponsor has been bogged down by bureaucracy, which is always defended by the phrase “that’s the way we have always done it”.

Daily

4.3.2. PM Stop any tasks that don’t help achieve the project goals. Too often, especially with complex problems, we get bogged down with unnecessary tasks that dilute our efforts.

4.3.3. PM Project team members become inspired when they have belief that they will be successful, and that belief can only come through understanding.

When we simplify things, it allows us to increase our Focus. It’s very difficult to focus on something complex.

4.4. Transparency

Transparency is about truth and knowledge. The truth about where we are and what our real performance is, and the knowledge of what we need to do to successfully complete the project, and where we are on the journey towards the project goals.

Without this transparency, it’s impossible to communicate our vision of the project to Sponsor, and the plan to achieve the project goals, to Project team members in order to inspire them.

Without transparency, everyone simply don’t know where we are.

4.4.1 PM Be transparent with Sponsor from the very beginning of the project starting at the RFP stage.

Most projects fail, or get into trouble because they are usually more complex than initially thought. They are like icebergs: it’s easy to see the top third, but it’s the two-thirds beneath the surface that cause problems.

To avoid this:

Do the due diligence at the RFP stage to understand what’s beneath the waterline;

Estimated project plan and budget accordingly.

4.4.2 PM Provide full transparency to Sponsor into project progress.

Important! Create project dashboard in RM and allow Sponsor and Project team access via Internet link.

Important! If Sponsor is ready for small extra PTC (about $10 per user per month) suggest Sponsor the full access to PJ as a member of a Project team.

Communicate the project status to the Project team



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during members to motivate them to continue onwards, during the final stages, to ensure success.

4.4.3 PM Regularly update project status in RM in accordance with Appendix I - Project status metrics and milestones.

See Appendix I – column “Check”

4.4.4 PM Send Synergy-wide announcements when achieving project milestones congratulating and cheering the Project team members.

As occur

4.4.5 PM A side benefit of transparency is that the higher the transparency, the easier it is to hold Project team members Accountable. So as you increase the level of transparency you increase the probability of project success.

5. Appendices

Appendix I – Project status metrics and milestones

6. Reference Documents

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Appendix I – Project status metrics and milestones

Mertic/Milestone Unit Project status in Roadmap

Owner Control Check On Schedule At Risk Critical

Submission Date Delay 0 1 week 2 weeks PM Head PM weekly

Approval Time days 60 90 120 PM COO monthly

First Site Initiated (FSI) Delay 0 1 week 2 weeks CRA PM weekly

First Patient In (FPI) Delay 0 1 week 2 weeks CRA PM weekly

FSI to First Patient In days 7 14 21 PM Head PM daily

Sites within 60 Days after FSI % 70 60 50 PM Head PM weekly

Recruitment vs Planned % 100 85 70 PM Head PM weekly

Last Patient In Delay 0 1 week 2 weeks CRA PM weekly

MV Reports On Time % 100 90 80 CRA PM weekly

Last Patient Out (LPO) Delay 0 1 week 2 weeks CRA PM weekly

LPO to Database Lock week 1 3 5 DM PM weekly

DB Lock to CSR Draft days 30 40 45 MW PM weekly

Study Report On Time Delay 0 1 week 2 weeks MW PM weekly

https://app.projecis.com/Project/1100/File/Details/39529

SOP-PM-02 FAST Project Management.pdfSignature Log

Version: 1Uploaded By: Igor StefanovUploaded On: 2/13/2015 4:55:11 PM (UTC+04:00) Moscow, St. Petersburg, Volgograd

NAME REASON DATE

Ekaterina ChuvikovskayaQA ManagerSynergy Research Group

New SOP 2/13/2015

Igor StefanovCEOSynergy Research Group

New SOP 2/13/2015

Evgeny PoltanovHead of Project ManagementSynergy Research Group

New SOP 2/16/2015

Yuri AfonchikovChief Regulatory OfficerSynergy Research Group

New SOP 2/16/2015

https://app.projecis.com/Project/1100/File/Details/39529

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SOP PM-02 FAST project management v1-signed