Clinical Study Manager

Highly Competitive Salary
  1. Permanent
  2. CRA Manager, Project/Study Manager (CSM/CPM), Clinical Outsourcing
  3. United States
Collegeville, USA
Posting date: 19 Oct 2020

Proclinical is currently recruiting for a Clinical Study Manager with a pharmaceutical company located in Collegeville, PA.

Job Responsibilities:

  • In house/outsourced studies, multi-country late phase study management.
  • Accountable to ensure all relevant studies follow SOPs and GCP.
  • With direction, 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 Clinical Operations functional groups (Regional Monitoring, Data Management, stats, clinical supplies and Operations Management) to ensure on time delivery of studies.
  • Work closely with the LOC study managers and address any study related questions, address issues related to study drug supply.
  • Manage sites/countries transitioning from study to commercial supplies either via CROs or via LOCs.
  • Manage study budgets
  • Escalate issues as needed to the Clinical Investigational Lead/medical monitor.
  • Provide input into identifying implications of study progress upon overall timeline goals conduct plans.
  • With oversight manage study start-up, conduct and close-out.
  • 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.
  • Provide input into development of CRF.
  • Provide input into site selection with coordinated input.
  • Aptitude for clinical systems, can do attitude, ability to work across projects/studies.
  • Senior stakeholder management and collaboration with partners.

Skills and Requirements:

  • Minimum qualification is a bachelors science degree or equivalent is a related discipline.

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.

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.