Clinical Study Manager

Highly Competitive
  1. Contract
  2. Project/Study Manager (CSM/CPM)
  3. United States
Collegeville, USA
Posting date: 09 Oct 2019
CR.SB.25774_1570633569

Proclinical is currently recruiting for a Clinical Study Manager for a pharmaceutical company located in Collegeville, PA. Successful candidate will provide input into identifying implications of study progress upon overall timeline goals conduct plans.

  • Collaborate with Clinical Operations functional groups (Regional Monitoring, Data Management, stats, clinical supplies and Operations Management) to ensure on time delivery of studies to required quality standards
  • Assist with maintaining relationships and monitor performance of CRO's and other vendors.
  • Work closely with the LOC study managers and address any study related questions, address issues related to study drug supply.
  • Manage study budgets
  • Ensure accurate maintenance and archiving of study records including eTMF.
  • Escalate issues as needed to the Clinical Investigational Lead/medical monitor.
  • Global CRO contract set up/renewal/extension & task assignment and oversight through to end of the studies currently which are currently in maintenance phase, additional vendor contracting, management and oversight
  • Management of CRO's or other outsourcing partners as appropriate
  • Accountable to ensure compliance with GSK SOPs and GCP.
  • With direction, may matrix with key study conduct partners.
  • Assist with maintaining relationships and monitor performance of CRO's and other vendors.
  • With direction from Senior Clinical Staff, collaborate with internal and external functional groups to ensure on time delivery of studies.
  • Work closely with the CRO study/project managers and address any study related questions, address issues related to study drug supply.
  • Support management of study budgets
  • Ensure accurate maintenance and archiving of study records including eTMF.
  • Escalate issues as needed (eg to the medical monitors or clinical leaders).
  • With oversight manage study start-up, conduct and close-out at CRO.
  • Assist in the management of CRO's or other outsourcing partners as appropriate.
  • Provide input into content and execution of investigator meetings / may present selected topics.

Skills and Requirements:

  • Global Study Management experience in Clinical Operations,
  • Be a team player with a focus on excellence and proven operational delivery.
  • Aptitude for clinical systems, can do attitude, ability to work across projects/studies.
  • Some flexibility is required to work with the wider global team in different time zones.
  • Ability to work within a complex matrix and fast paced environment is essential.
  • Previous HIV or GSK experience would be preferable but is not essential.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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#ClinicalResearch

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