Project Manager I (Clinical)

Integrated Resources Inc.; Northborough (MA); Presencial; USD 80.000 - 100.000; Tempo integral

Resumo da vaga

A leading healthcare IT service provider is seeking a Project Manager I (Clinical) to manage the demand for investigational products within international clinical trials. The ideal candidate will possess a strong background in clinical development, excellent communication skills, and the ability to navigate regulatory landscapes. This long-term position offers opportunities to work on innovative healthcare solutions and a chance to influence patient engagement positively.

Qualificações

• Pharmaceutical industry experience required.
• Must be well versed in GMP, GCP, and regulatory requirements for clinical supplies.
• Experience in project development and clinical supplies process.

Responsabilidades

• Manage the Demand for Packaging & Distribution of Investigational Products for International Clinical Trials.
• Establish Supply and Distribution Strategy with customers.
• Set up and maintain customer services relationship for long-term loyalty.

Conhecimentos

Project Management

Clinical Development

Communication

Negotiation

Multitasking

Organization

Formação

Bachelor of Science (BS) degree

Masters of Science (MS) degree

Ferramentas

MS Office Suite

Project management software

Descrição da vaga

Saviance is a US Healthcare IT Service provider focusing on Patient Engagement with Innovative Products and Solutions like Patient Intake Tablet, iHealthConnect Wellness Portal, Mobile Applications, Actionable Analytics and ICD-10 Testing Services. Incorporated in 1999 in New Jersey, with over 15 years of excellent industry track record, Saviance offers services & solutions that enable enterprises to achieve critical objectives.

Saviance is a Gold Category Corporate Member with Healthcare Information Management Systems Society (HIMSS), member of mHealth Alliance and Corporate member of NJ-HITEC. We are awarded by INC. 5000 as one of the fastest growing privately held companies in North America. Saviance is also ranked among the Fast 50 Asian American Businesses in the United States by USPAACC (US Pan Asian American Chamber of Commerce) and selected as a 2014 "Top Business" recipient by Diversity Business.com. A certified Minority Business Enterprise recognized by NMSDC, Saviance is also partner with leading global brands such as Microsoft, Amazon Web Services, Apple, Samsung and Red Hat.

Job Description

Job Title: Project Manager I (Clinical)

Job Location: Northborough, MA

Duration – 12 +Months

Duties:

· Manages the Demand for Packaging & Distribution of Investigational Products for International Clinical Trials as well as for any other services proposed by the Clinical Supplies SCP to any customers.

· Act as single interface with customers and the Clinical Supplies SCP

· Represents the Clinical Supplies at the Project Team level .

· Lead the Clinical Supplies Project Team.

· Based on the customer project development plan, build the business plan for the project he/she is accountable for

· Estimate IP need with customers and consequent DP need and share at Project team level.

· Generate a service agreement for a program/study with the customer, containing technical specifications (packaging & labeling), IP Needs, timelines and related costs.

· Manage any change impacting the allocated budget, revise the business plan and service agreement accordingly.

· Establish comparator Supply strategy with customers.

· Establish Distribution Strategy with customers and IVRS providers

· Review and comment Project & Study documents (CIB, protocol, Monitoring Plan, IND/IMPD dossier,

· Set -up and maintain customer services relationship to gain and retain long term customer loyalty

Skills:

· Excellent knowledge of Projects Development and Clinical Development

· -Generalist profile combining a good knowledge on Preclinical Activities, Clinical Operations, Clinical Supplies Production and Distribution activities.

· -Excellent oral and written communication skills

· -Excellent negotiation skills: -Excellent skill in Project Management: ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization

· -Ability to organize and lead meetings -Experience with MS Office Suite (Excel, Word, PowerPoint), flow diagramming and project management software required

Qualifications

Education:

Bachelor of Science (BS) degree in a related discipline or Masters of Science (MS) degree in a related discipline with pharmaceutical industry experience.

The individual must be well versed in all aspects of the project development and clinical supplies process , GMP, GCP and other regulatory requirements as they pertain to clinical supplies