Title: Project Management in Medical Affairs
Start Date: July through end of 2018
On-site 5 days/week in Whippany, NJ
Length of contract: 5 months
- The Contract Operations Excellence & Project Manager is accountable for compliant and high quality management of assigned projects for RWE (real world evidence) programs such as MA Studies (both non and interventional), expanded access (EAP), Investigator Initiated Research (IIR), including advisory boards/steering committees, budgets, contracting & tracking.
POSITION DUTIES & RESPONSIBILITIES
- bility to manage assigned projects such as IIR program, EAPs and non & interventional studies.
- Work within team environment in concept/protocol development and ongoing management of all applicable assigned projects/ programs and internal review committees
- Develop and maintain effective working relationship with key investigators & thought leaders in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication
- Operationally lead and manage to ensure all deliverables are met according to timelines, budget, quality standards and operational procedures
- Report progress and issues with their resolution
- Assist in develop outsourcing specifications with respective line functions to facilitate selection of CROs/vendors; manage interface with CROs/vendors in cooperation with the appropriate team members
- Ability to work across functions and be able to leverage relationships to create and execute strategically aligned activities
- Knowledge & tracking of data ongoing, medical/scientific reviews, clinical reports, publications and internal/external presentations.
REQUIREMENTS/PREFERENCES Education Requirement(s):
* Bachelor's degree (life science preferred)
* Masters in Science or Business Administration - preferred Skill & Competency Requirements:
* 3 years of experience in pharmaceutical/biotech/CRO industry with Operational Study and/or IIR management experience (e.g. CRA, Study Manager)
* Oncology experience (can be outside of industry)
* Strong written, computer (e.g. Excel, power point) and communication Skills with a high degree of responsibility and accountability
* Excellent interpersonal, decision-making and organizational skills and ability to work in a global environment
Sthree US is acting as an Employment Business in relation to this vacancy.