• Positive Erbitux study data

  Merck KGaA has reported positive data from a clinical study of Erbitux in cancer patients.The...

• Studies suggest 'clinical benefits' of AZ lung

  AstraZeneca (AZ) says its cancer drug Zactima (vandetanib) has demonstrated "clinical benefits" in...

• See all news in this category

Global Clinical Research Manager

10 Oct 2008

This is a unique opportunity to join an international Clinical team's within one of the hottest biopharma's in the world. The position is the first Global Clinical Manager in country and with that they will establish and maintain excellent relationships with current and potential investigators.

Ensure quality of site validation and development of site-specific enrolment planning, including development of recruitment and retention strategies and tactics in collaboration with CROs, to deliver agreed patients to timelines. Close communication with sales and marketing functions to deliver fully coordinated local support of clinical research.


Main Responsibilities

Provide Site Management oversight of multiple clinical studies (phases I - III) to support Global execution of studies to meet regulatory submissions in compliance with GCP, all relevant local (and where applicable EU law) and Company SOPs within planned time and resource targets.

Partner with Global Clinical Operations, Regulatory and local Commercial teams to ensure broad alignment with the clinical development strategy at the Program, Therapeutic Area and Portfolio level. Works closely with Clinical Program Leaders, CTMs and Contract Managers as applicable to provide site selection and patient recruitment strategies.

Identify and develop investigators that support product development, conduct protocol scientific, medical and operational feasibility assessments to provide feedback to Global Clinical Operations on the protocol design.

Ensure quality of site validation and development of site-specific enrolment planning, including development of recruitment and retention strategies and tactics in collaboration with CROs, to deliver agreed patients to timelines.

You will interact with; Clinical Program Leader, CTM, CPL, Medical Research physician, Medical Director in Affiliate, on a daily basis. All staff in affiliate where Study Manager is

Works with the Clinical Program Leader, CTMs, and relevant Medical and Country-specific personnel to plan and hold investigator meetings at both country and regional level to enhance patient accrual and utilize learning's.

Support the SMT and contracted CRO local Lead in site identification and conduct of Site Qualification Visits to validate potential sites' ability to conduct the study and recruit an agreed number of patients. Position holder will establish excellent relationship with local lead from CRO to benefit site and BIIB study/program team.

Conduct face to face protocol scientific and strategic/medical feasibility with a few potential investigators that have the appropriate patient population and provide documented feedback to the CPL on the study design, subject availability and relevance of the protocol design, comparators etc to established local clinical practice


Qualifications

Considerable experience in Clinical Research, ideally having worked in a matrix environment.

A self starter with excellent interpersonal skills.

Strong mix of science and operations to enable position holder to discuss compound, development plans, protocol, endpoints with investigator site personnel thus positioning BIIB ahead of our competition for knowledge, relationships and planning.

Sufficiently operational to ensure sites proposed for use in study are operationally feasible. Note: detailed site qualification will be conducted by the selected CRO.

Educated to degree level essential in a life science, medial or related discipline.

For further information please contact
Rowena Weighell
Email: rowena.weighell@hayspharma.com

Services advertised by Hays Pharma are those of an Agency and/or an Employment Business