Clinical Project Manager/ Senior Clinical Project Manager at UK - Home-based Role
- Experience Level
1 JOB PURPOSE SUMMARY
To carry out all duties, as defined in the Contract, relating to the Project Management of national/international clinical trials in compliance with ICH GCP, regulatory requirements and study specific procedural documents. To navigate the clinical trial through challenging situations, working proactively and providing solutions and to deliver quality projects to set timelines and within budget.
The Project Manager will be involved in a range of activities prior to project award, from the input into new proposals and participation in Bid Defence Meetings, through to project award and the set-up, conduct and closing of a clinical trial.
The Project Manager has overall responsibility to manage the completion of all tasks assigned to Orphan Reach, including work conducted by the collaborative Partners and Vendors on behalf of Orphan Reach, to the standards and expectations of the Client.
3 KEY RESPONSIBILITIES AND ACCOUNTABILITIES
o Assist Business Development with Scope of Work and Budget completion, defining tasks and resource requirements
o Participate in Bid Defence meetings
STUDY START UP
o Conduct Handover Meeting from Business Development to the clinical team ensuring all relevant parties are included and informed of every aspect of the trial, including their FTE and allocated budget.
o Select suitable Clinical Study Team members conducting interviews where necessary
o Conduct a Kick Off meeting with the Sponsor and the study team and meetings with the internal team, Partners and Vendors as required
o Establish roles and responsibilities, budget and invoicing practices.
o Prepare key project management documentation, e.g. Project Plan, Communication Plan etc., in line with Client requirements
o Organise and/or participate in Sponsor/Project team/Investigator meetings
o Ensure contracting parties are aware of any operational changes that may impact the study
o Ensure process is defined with the sponsor regarding out of scope work
JOB DESCRIPTION – Senior Project Manager
JD – PM V28/03/2016 WI-016 Version 1 Page 2 of 2
o Assess study resource and changes to ensure adequate levels to conduct study activities agreed at the current study contract.
- Participate in the development/review and maintenance of all study related documents, templates, plans, manuals, Trial Master File and site investigator files
- Perform Regulatory and Ethics co-ordination, ensuring QC of all packages and sending to Sponsor
- Work with team members on the preparation of packages (Competent Authorities, central and local Ethic Committees/Independent Review Board) submission, responses to gain approval.
- Establish communication channels to the study team, sponsor and vendor teams within Scope of Work
- Develop a communication plan where applicable
- Ensure project is running according to timelines
- Ensure project is running according to budget, review the profitability reports monthly.
- Participate in Site Selection and attend Initiation Visits as required
- Familiarise project team with therapeutic area, protocol, Investigator Brochure (IB) and identify any training needs for the team or individuals, ensuring all training events are documented.
- Agree contract templates, review and assist with negotiations of contracts and wording for: - (investigator, site, laboratory and any other).
- Track any payments generated and liaise with finance where applicable.
- Co-ordinate any translation of study documents (Contract, Patient Information sheets, regulatory and Ethics Submission and approval documents) using Orphan Reach internal process
- Liaise with local suppliers/CRAs to establish the requirement to obtain import and export licenses for Investigational Product or other study related shipments
- Perform Regulatory Green Light
- Ensure Confidentiality Agreements are in place prior to release of any information to vendors, sites, suppliers etc.
- Ensure all work performed is under a Letter of Intent, Contract or written approval from the Sponsor or Vendor.
- Prepares reports or trackers on study status at determined intervals within the SOW.
- Ensure Serious Adverse Events are reported within the timelines and are appropriately followed up, liaising with pharmacovigilance/safety department.
- Troubleshoot/be proactive/find solutions
- Perform co-monitoring or motivational visit to site and assess CRAs and site performance
- Maintain oversight of project activities including query resolution, interim analysis and Database lock and send oversight reports on an agreed frequency to the Director of Clinical Operations.
- Participate in audit and inspection processes.
- Participate in reviewing or responding to issues and findings
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