Project Manager - Charleston, United States - Novotech

Description

Job Description

Responsibilities:
Project Management

• Determine project feasibility, considering the needs of the sponsor as required to assist Business Development. Actively provide guidance and review scope of work, responsibilities, timelines and quality of deliverables.
• Ensure set up and maintenance of operational project plans, timelines & study tracking tools (such as CTMS), and eTMF, as required.
• Work with the Vendor Manager to assess, appoint and manage study vendors to ensure the study is adequately supported, e.g. central laboratory, drug distributors, IRT providers.
• Work collaboratively with Associate Project Managers in study management and with cross-functional project teams, such as Clinical, Regulatory, Medical, Biometrics and Pharmacovigilance.

General:

• Assist in the review and development of SOPs and processes. Identify areas of inefficiency in process and make recommendations to management for improvements.
• The Project Manager may be asked to participate in Bid Defence Meetings.
• Represent Novotech at industry forums (conferences, professional association, committee work, international investigator meetings).

Minimum Qualifications & Experience:

• Graduate in a clinical or life sciences related field.
• At least 5 years' experience within the clinical research industry and previous project management experience, including Associate Project Manager or
  equivalent.
• CRO experience is advantageous.

Salary Band - Project Manager: $125,000 USD - $155,000 USD - The salary for this position will be determined based on the candidate's experience and qualifications.

Find out more about working at Novotech at: www.novotech-

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

About Us

Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

About the Team

Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.

It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.

As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.