Project Manager Associate

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North America
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Permanent / Full-Time

MRN is the largest and most experienced global provider of community-based trials and site nurse support solutions for the clinical trials industry.

Where within the MRN will I be working…

This exciting role sits within our Project Management team who have the overall responsibility to deliver MRN operations efficiently. Specific activities include delivery of Home Trial Support, Site Nursing Support, and Central Pharmacy projects related to overall execution of global clinical trials.

About the role…

As a Project Manager Associate, you will be assisting the delivery of projects to ensure they on time and within budget, and in accordance with international laws and guidelines working under the supervision of the Project Manager (PM) and/ or Project Director (PD).

You will also take lead on maintaining and enhancing internal and external relationships with an operational and commercial focus.

Some duties include:

  • Part of study team to include, Operations, Nursing, Vendor Contracts Management Team (VCMT), proposals and contracts (P&C), Pharmacy and Quality staff to plan, manage, track and monitor projects to ensure they are delivered on time and within budget, in compliance with MRN procedures and applicable regulations
  • Guided by the Project Management Office (PMO) provide accurate and timely information to the Project Management Group Head (PMGH), PD, PM, clients and sponsors on overall project performance including both financial and operational aspects
  • Undertake activities as described below and participate in specific activities as defined in MRN RACI or appropriate study delivery plan/ study activities

Study Start up:

  • Advise on the creation and implementation of individual plan(s) for assigned project(s), as applicable, to include an assessment of potential risks to the project delivery and a contingency plan. Use tools such as MS-Project and the service detail specification
  • Manage and participate in internal and external kick off meetings, with insight of study objectives and customer requirements
  • Coordinate cross-functional project activities, as appropriate in the study delivery plan
  • Assist the PM in managing the creation and production of study documents. e.g. VRF, SRF, POF by the appropriate functions/ personnel
  • In association with VCMT, PMO, Visit Management (VM) and other Project Management personnel, coordinate set up of MRN corporate systems and tools. e.g. MsP, SMART, TEC, study tracking Project Plan spreadsheet
  • Attend sponsor/client meetings, minute meetings; includes meeting preparation (review of study reports, metrics)
  • Assist PM on VCMT, VM led supplies procurement actions for assigned studies, includes tracking and following up on requests

Recruitment/ Ongoing studies:

  • Use study metrics to track and report activities internally and externally, coordinate generation of metrics alongside PMO, where applicable. Provide regular data summaries to PM/ PD
  • Report to PM on HcP onboarding and visit readiness status in coordination with visit management and nursing (study training) team
  • Provide input to PM in risk management and mitigation of HTS visit activities.
  • Work with study team to anticipate issues and resolve in a timely manner. Track issues on study log and ensure appropriate dissemination of information to relevant departments.
  • Ensure appropriate filing of study documents and emails
  • Help the PM with study budget oversight and routine invoicing, reconciliation, forecasting and management activities; this may include and is not limited to budgetary query resolution, margin awareness and change order processing.
  • Assist the PM in revision of study requirements in line with client/sponsor requests resulting from study process and protocol amendments.
  • Develop positive relationships with clients, sponsors, vendors and sites
  • Act as a liaison, alongside PM, with cross-functional team members to ensure timely completion of all deliverables in study setup and tracking of data in ongoing phase of study
  • Track progress of key performance indicators (Site, Patient, Visit, HcP Progress) and key quality indicators (issues, corrective action and preventative actions, quality gates) identified by PM or PD
  • Prepare and distribute project status reports to PM, including metrics on key milestones of the project plan, key performance indicators and key quality indicators, contribute to governance meetings, as necessary.
  • Assist PM with identification and communication of risks, issues and needs on projects

Study completion/ Close-out:

  • Assist the PM on study close-out processes and activities
  • Ensure all equipment is returned/accounted and other study material destroyed.
  • Undertake study archiving according to MRN and any the sponsor specific requirements
  • Provide assistance on financial reconciliation at close-out

Skills, Experience, and Qualifications…

We are looking for talented individuals who have working knowledge of ICH GCP and appropriate regulatory laws and guidelines. Individuals who have the ability to multi-task, problem solve and priorities a complex workload is a must.

It’s Essential you have:

  • Experience working with a sponsor/CRO, and or site clinical research experience.
  • Degree in a science/medical based subject, or have equivalent experience
  • Awareness/working knowledge of ICH GCP and appropriate regulatory laws and guidelines
  • Awareness of project financial management
  • Ability to multitask, problem solve and prioritize complex workload
  • Computer literate –intermediate skills in MS office Excel, Word, Outlook, and MRN systems

Equality, Diversity, and Inclusion

We are an equal opportunity employer who values diversity. Our aim is to work simultaneously to promote a more inclusive and safer environment for everyone, which attracts all candidates and portrays our commitment to celebrate and promote diversity.

Data Protection – Your Rights

Should you apply for a job opportunity at the MRN, we wish to inform you that it is our intention to retain the personal data provided by you for up to 2 years from the date it is received, at which point you will be asked to provide new consent. If you have any questions or concerns regarding our processes and how your personal data will be stored, please contact us for further reassurance.