Description:
Clinical Project Manager

Location: United States - Waltham, MA

CROMSOURCE is looking for an experienced Project Manager to join one of our partner pharmaceutical companies in Waltham, Massachusetts. This is a full time, permanent job opportunity.

The Project Manager will be responsible for CRO and vendor management (labs and clinical supply logistics) whilst assuring the co-ordination of the operational aspects and proper conduct of a clinical study, including compliance with ICH/GCP and Client policies and standard operating procedures.

The successful candidate will be working on studies dedicated to one client.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

Main Responsibilities and Accountabilities:

• Execute clinical strategies to deliver successful operational outcomes across multiple clinical trials.
• Manage, plan and execute clinical studies, including creating and managing study timelines, budgets and study management plans in an outsourced model.
• Lead the selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution.
• Manage study operational plan and CRO activities, including project timelines and quality of deliverables, and managing approved trial budget(s) throughout the life of the clinical trial(s).
• Maintain frequent and meaningful contact with CROs to assess performance and provide guidance as needed.
• Develop and manage study timelines (including recruitment).
• Develop and manage program timelines when necessary.
• Liaise with clinical staff and Investigators to ensure optimal Sponsor site relationships.
• Author clinical study protocols, ICFs, CSRs and other clinical documents as required.
• Partner with CMC to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials.
• Manage study progress from planning to close out to ensure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP and ICH guidelines.
• Assist with development and implementation of policies and SOPs to be used in Clinical Operations.
• Lead, plan and execute clinical investigator meetings, study meetings and vendor meetings as needed.

Education / Qualifications / Experience:

• Educated to degree level (biological sciences, pharmacy or other health related discipline preferred). Masters is preferred.
• Substantial experience with Clinical Research in the pharmaceutical/biotechnology industry, including previous Global Study/Project Management experience, whilst at a CRO or pharma company.
• Vendor management experience, including CRO, laboratory and clinical supply logistics management.
• Experience with Infectious Diseases preferred.

Skills and Knowledge:

• Proven negotiation experience with vendors and sites.
• Experience managing budgets and timelines.
• Ability to interface with medical personnel at clinical sites.
• Understanding of drug development from pre-IND through NDA.
• Thorough understanding of FDA, ICH and GCP guidelines
• Excellent interpersonal, verbal and written communication skills.
• Knowledge of Project Management software
• Client focused approach to work.
• Excellent team leadership skills.
• Ability to motivate both individually and collectively.
• Excellent problem solving capability through early identification.
• Demonstrate, appreciation and understanding of finance and budgeting issues.
• Excellent computer literacy.
• Competent in written and oral English.

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001590 .

If you would like to discuss the role before applying through the website , please contact Holly.Price@cromsource.com for more information.

Why choose TalentSource Life Sciences/CROMSOURCE?

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge

CROMSOURCE comes from the merger of MSOURCE and CROM in 2011 and we are great at recruitment and staffing services! We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide, securing great global talent. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

For the client client-facing positions, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client.

How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Key words: Project Manager, Clinical Project Manager, Study Manager, PM, SM, Project Lead, Study Lead, Vendor Management, CRO Management, Infectious Disease, Antibiotic, Permanent, Full time, CRO, Contract Research Organisation, Biopharma, Pharma

Skills: Project Manager Location: United States- Waltham, Massachusetts