Clinical Trials/ Integration Project Manager

3 weeks ago

Lake Forest, United States Precise Solutions Full time
Job DescriptionJob DescriptionAt Precise Solutions, we are looking for top talent consultants to bring on as employees of our organization and service our clients in the various Life Sciences Industries.  We are much more than a consulting firm Precise Solutions provides competitive compensation packages with great salaries, benefits, health insurance, paid time off and employer-based 401k contributions. 

We currently have an immediate need for the following:

Job Title: OCM Project Manager
Location:  Lake County, IL USA
Compensation:  $57.00 per hour, Paid Time off, Company 401k contributions, Health, dental, and vision insurance.  Total Annual Compensation including benefits is $ 131,000.00
Resume Requirements
The following resume requirements must be met for resume to be considered
  • Candidates first and last name (legal spelling) must be at the top of the resume
  • Valid email address must be at the top of the resume.  LinkedIn links will not be accepted it must be a valid email address so our recruiters can respond to your resume
  • Please refrain from submitting resumes with candidates photo they will not be considered
Hiring Manager OverviewI am the head of clinical data strategy and opsmy organization is accountable for collection of clinical data in each clinical trialsonce all of the data is collected we do "cleaning" of the data. We also build the systems used to collect data.4 dif. systemswe have offshore presence in India who do data cleaningwe also do data insights tools, we interact with statistical programmers and statisticians and take that to approvalwe recently purchased an oncology research companycompany of 250 people, oncology companywe have sister function within this new company but it is very small group but because they have different models and skill sets its important we integrate their systems into our own and as seamlessly and with as little disruption as possible.Also don't want to miss opportunities to improve our own operationswe need a PM who can work with both the newly acquired company and the mother company so that we are seamlessly integrating into a single operating model.we have been working on the blueprint for last 2 months and the project is already underway.We have had the opportunity to interact freely with Immunogen and we are getting to the point where we need to do heavy lifting as far as Project Management goes.The PMs most important is experience is doing multi company integrations which is a hard ask no doubt.Nice to haves in order of importance from Left to Right are Life Sciences, Domain knowledge, Knowledge of clinical environments and knowledge of clinical operations and even some data management experience would be better.Next is some level of work with IT and integrationsAlso a multi-vendor environment experience

Clinical Trials/ Integrations PM Top Skills and Preferences
  • Experience with using Clarity PPM
  • Familiarity with Organization Change Management experience/knowledge
  • Matrix team leadership
  • X-company integrations
  • Level of technology aptitude since we will be dealing partly with data/systems migration
  • Domain expertise would be helpful – clinical development, sub-function = biometrics (statistics, statistics programming, data management)
Clinical Trials/ Integrations Project Manager Specific Responsibilities
  • Drive Project Success and Completion: Understand and drive leadership of the project to success. Build key relationships with stakeholders, mentor team members and demonstrate leadership at all levels.
  • Initiate and Plan Project: Works with business and IT management to establish and gain consensus on project goals, objectives, financials, and deliverables.
  • Project Control: Assess the degree to which changes to scope, issues and risks will affect the project, working with business and IT management and sponsor to gain agreement for resolution. Measure performance to assure the project is progressing as compared to original plan and budget.
  • Executing and Closing Project: Develops and executes a work plan obtaining authorized resources to ensure all activities are performed. Leads team in delivering project scope. Gather lessons learned and obtain final project approval from sponsor and stakeholders.
  • Project Communication: Communicate project progress by producing project reports to provide timely and accurate project status and decision support information to project teams, business, and IT management. Makes recommendations based on current project status to resolve issues and manage risks.
  • Resource and Team Management: Coordinate resources to ensure project needs are addressed and effectively assign tasks and deliverables to team members based upon their abilities. Motivates project team to deliver project outcomes.
  • Quality Management: Responsible for compliance with applicable Corporate and functional policies and procedures.
  • Decisions: Make decisions that impact project level activities.
  • Drive Continuous Improvement of Project Process and Governance: Will continually examine Plans/Risks/Issues to identify gaps in project communication or process, and holding project team accountable for improvement, to drive proactive solutions as the project is ongoing. Escalate issues that need permanent process changes.
Clinical Trials/ Integrations Project Manager Q&A

What would you say is the biggest challenge out of the gate? Probably the people part. Its not that they don't work well its that they come from two different integration models. It is mission critical that we make sure the playing field is kept level. Biases left to the side and no feeling of one side being better than the otherWhat technical aspects are required? The ability to work in Excel at high level as well as Power Point presentations at a high level. SmartSheets would be good but not required. From tech standpoint that is most criticalCan you go into the nice to haves a little more? Yeah systems environment for our particular domain. That NTH is related to fact that our operating model at AbbVie is so unique that we have our own systems. At Immunogen they use contracted CRO systems . Eventually they will be combined so knowing GcP and regulatory background is highly beneficial. Are there any other nice to haves that you can elaborate on? When we think about Matrixed leadership there is obvious where we integrated 2 different companies. As mentioned, this is a sensitive environment and everyone is kind of doing things the way they have been doing and we need OCM control as we integrate. We had a very successful integration that went very well and we want to duplicate that successQ&A--ContinuedIn regards to X-Integrations what experience should they have? For me the experience of having integrated companies is really the key it is such a unique experience and the ability to navigate difficult situations with finess is critical. Unless you have this experience I can't see how you could do this. Also that Matrixed leadership is a critical must haveClinical PM or IT PM with M&A? An IT PM is not appropriate, this needs to be someone with experience across people projects and technology. I don't want to go too far into technology area, they definiteley need people and processes. So Clinical Trial Project Management is what we want.Data migration from CRO data systems into a central AbbVie data systems and probably during that time we will start new studies using AbbVie technology but we will be researching integration of those systems at unigenOnsite? Onsite is not required, there may be specific situations where they may need to travel to Boston or Lake County but they can be virtual until that arisesIs M&A experience required? No, I need integration experienceBiometrics or other specific clinical trials experience they should have? They need to be proficient in anything I had mentioned earlier. Knowing the nomenclacher is important and knowing how the different systems are used given the biometrics they are in.Is SAS or other programming languages required? All the data once it is ready to submit the statistical programmers who then develop tables, listing and graphs. That's how the FDA is able to review our submission so they use SAS or R as main programming language.Life Sciences? It is the number one nice to have

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