Global Study Manager, Biotech - Based in Middlesex
We're looking to identify a very capable contractor to function as a global study manager within a biotech environment. Ideally you will have managed studies working with external clinical vendors. You will lead affiliate and vendor managed studies from a HQ perspective. Ideally we are looking for someone who has prior experience in management of international studies and who can be effective from Month 1.
To apply you will need to beable to work full time. You will be competent to lead study start up and delivery within a global matrix setting and willing deliver operationally at project level including budgetary oversight.
You'll be supervising the workflow of others as well^from a project stand point and mentoring and supporting country level liaison.
Summary of Duties:
Planning and managing clinical operations for assigned clinical projects, including timelines, budgets, personnel resources, investigational sites, vendors and key project deliverables
Manages, mentors and provides professional development guidance to assigned clinical operations staff members.
Provide strategic planning expertise, drafts the operations components, and ensures operational^feasibility of clinical development plans and scenarios, including budget and resource estimates.
Manage the preparation of clinical sections of Investigational New Drug (IND) submissions, IND annual reports,investigatorbrochure updates, BiologicLicense Application (BLA)/New Drug Application (NDA) submissions, NDA annual updates and clinical study reports.
Convene and lead cross-functional clinical teams.
Coordinate and drive completion of the protocol concept, final protocol and template^informed consent form.
Develop outsourcing specifications for vendor requests for proposal and scope of work agreements.
Participate in and guide study team in vendor selection and management throughout the life ofassigned clinical projects.
Work with study teams to determine patient recruitment strategies and operational feasibility and implementation of study objectives.
Author and refine clinical operations plans and study monitoring plans.
Lead ongoingstudy team review of data.
Manage and communicate to senior management overall clinical strategic operations plan for projects including timelines, internal and external resources/costs, key deliverables and key data issues.
Plan, convene andpresent at investigator meetings.
Draft study site agreements and budgets.
Develop and manage study timelines.
Essential Skills & Qualifications Required
BSc (Life Sciences) or Nursing Qualification
Ideally a further degree
Prior experience in oversight of clinical research vendors (CROs, central labs,imaging vendors etc)
Project planning experience including oversight of study deliverables, budgets, and timelines
Experience writing and presenting clearly on scientific and clinical issues
Experience collaboratingand leading cross-functional teams (team/matrix environment)
Fluent in English
Software Competence Required
- Intermediate MS WORD, - Intermediate EXCEL, - Intermediate Powerpoint
Employer: Biotech Company
Employment Type: Longterm RollingContract PAYE or subcontract
Hours: Full time
Initial Contract Term: =12 Mths
Location: Office Based near M4, West London
Plan Start Date: Late June or earlier
Please do not apply if you are unabletomeet this start date.
Clinical Research, Clinical Operations, Clinical R&D, CRA, CTM, CTA, GCP, Site Manager, Monitor, Manager, Study Manager, EUCTD, ICH GCP, Project Manager, Clinical Study, Clinical Programme, Feasibility, Budget,vendor, RFP,variation, scope,outsource, CRO selection, Contracts, Clinical Trial Agreements, C&O. Bids, Proposals, Negotiation, Accruals, Financial, Clinical Study Report,CSR
Assigned Consultant: Avril Horn on 01932 234686 or Gabrielle Gainsborough on 01932 234682 at CSL
Pleasefeel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs, applicants will only receive feedback if they are suited to the role. The role may have been remarketed; if you applied for this rolepreviously and were unsuccessful you will not receive a response. We are unable to respond to applicants who are not EU nationals unless they include evidence of right to work in full time employment with their application. Do apply with relevant information on required location or salary/day rate if you are a new candidate.