Clinical Program Manager, Early Development - Contract role
Pharmaceutical Company based in the South East
My client has an opening for a capable Contract Program Manager. The role has arisen due to a specific business need and this person will^be assigned to oversee a small number of key clinical projects within a regulatory support study programme for a period of up to 12 months.
I am looking for an experienced program and people manager who is 'hands on' involved with study delivery^and design and able to deal easily with regulatory, scientific, functional and budgetary aspects within a lean and resourceful setting whilst maintaining control and managing information flow globally.
I am not considering candidates who have been^managing studies through PMs or large scale outsourced studies instead someone who can still influence delivery first hand and problem solve in the EU arena in any regard.
As the role in located in the South East you must be located in the Home Counties within an hour of London ideally and able to work office based and full time. Our ideal candidate will have risen through the ranks from a role as a Clinical Scientist, worked within a Pharma R&D company at some stage and someone who relishes 360 roles working across project lifecycle and regulatory within a small cohesive team where scientific rigor is the norm.
Design and lead studies within a programme, from clinical development planning to delivery of a final clinical study report.
Manage remote vendors, internal resources and key opinion leader contacts throughout a study lifecycle to enable robust study design and delivery, but also credible progress to agreed timelines and budgets.
Manage budget, work^scope, variations to contract and milestone delivery from vendors.
Lead cross functional team delivery evaluating resources, risk, contingency and quality components.
Regulatory liaison, input to CTAs, dossiers, core documents and safety reports relating to assigned programme.
Evaluate operational delivery at site level enabling prompt resolution, risk management, safety assessment, regulatory compliance and inspection readiness in close liaison with quality.
Skills & Qualification
Life science qualification, higher degree desirable
Significant expertise in study delivery in Phase I, II and/or III
Knowledge of clinical development planning and experience of protocol writing
Prior expertise in the delivery of clinical study reports to current standards
Established record as a team leader with hands on practical ability to deliver projects to timelines, budget and quality parameters.
Expertise in managing vendor placed and company managed studies.
Capability to inspire others, credibility and scientific ability in the clinical R&D arena.
Fluent English language skills
UK Driving License and vehicle
Software Competence: MS Office, MS Project
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: Yes
Employer: Pharmaceutical Company via an agency
Employment Type: Consultancy Agreement or PAYE
Hours: Full time
Contract Term: 12^Months
Location: UK; South East
Plan Start Date: ASAP
This post has been marketed previously as 7435 and 7502. If you applied previously please do not reapply we are reviewing candidates who applied again now following a late development in this campaign.
MS Office, MS Project. Clinical Research, Clinical Operations, Clinical R&D, Study Manager, EUCTD, ICH GCP, Project Manager, Clinical Study, Clinical Programme, Feasibility , Essential Documents, GCP, SOPs, Compliance, Training, Investigator Meeting, REC, Research Ethics. R&D, Trust, SMO, Site Manager, Quality Control, QC, EDC, Registration, Regulatory Affairs, Clinical Trial Applications, Budget, vendor, RFP, variation, scope, outsource, CRO selection, Contracts, Clinical Trial Agreements, C&O. Bids, Proposals, Negotiation, Accruals, Financial
Quality Assurance, Audit, Inspection, Pharmacovigilance, Safety
Assigned Consultant: Ann Maloney at CSL Recruitment on 01932 228 928
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs; applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be remarketed; if you applied^for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information^on required location, notice period and expected salary/day rate if you are a new candidate.