Project Manager-CRO - New Providence, United States - Evolution Research Group

Evolution Research Group New Providence, United States

3 weeks ago

Description

Job Details

Job Location
LOC400 CRO Remote - New Providence, NJ

Project Manager-CRO (remote)

Job Title:
Project Manager

Location:
Remote

Job Description:

The Project Manager is a proven leader in clinical program management in the clinical research industry, and manages, executes, and reports on clinical study operations.

This position provides leadership and support to members of the multidisciplinary project team, internally and externally. Responsibilities encompass the overall management of a project including budgeting, timeline adherence, internal and external communications, and project deliverables.

Under limited to no supervision, act as the liaison between the sponsor, team members, and sites while managing projects to ensure quality service.

This position will be part of the Clinical Operations Team, which is responsible for planning, executing, managing, and closing projects associated with the company clinical study plans.

Essential Duties and Responsibilities:

Assume primary accountability for assigned clinical research projects and ensure compliance with applicable regulations, guidelines, and corporate policies for study activities.

Manage and execute the overall project scope, budget, and timelines. Identify project success factors for analysis, reporting, and tracking.
Manage resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, and contractual agreements.
Lead the development of study specific protocols, consent forms, and other trial related materials as required.

Ensure the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.

Participate in the review of clinical data for analysis.

Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).

Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.

Plan for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device.

Monitor adherence to project contract and budget.
Coordinate with clinical, marketing, and operations management to identify goals and scope of clinical study projects. Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed.
Support the management and oversight of clinical study related vendors. Review site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements.
Provide therapeutic training and guidance to clinical team.
Enhance department and organization reputation by participating in departmental or corporate initiatives.
Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
Attending off-site meetings and conferences, as needed.
Perform other miscellaneous related duties, as required.

Education and/or Experience:

Bachelor's degree or equivalent education/degree in life science/healthcare is required accompanied by 5 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.

CRO experience is highly desirable.
Experience qualifying & managing external vendors.
Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies.

Experience writing, reviewing, and editing protocols and clinical study reports as well as working knowledge of the FDA submission process.

Skills and Abilities:
Ability to facilitate a teamwork philosophy with a positive attitude.
Extensive organizing and coordinating skills, teaching and facilitation skills, ability to assess training needs and objectives.
Extensive experience overseeing and coordinating the work of others.
Ability to work effectively and efficiently handling multiple tasks simultaneously.
Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
Ability to manage multiple deadlines.
Must have a 'can-do' attitude and a strong desire to take ownership of many different projects.
Strong computer skills, including Microsoft Office.

#J-18808-Ljbffr

Senior Project Manager

4 days ago

Nautilus Solar Energy LLC Summit, United States

Senior Project Manager · Position Summary · The Nautilus Solar Energy Senior Project Manager will be responsible for overseeing the ongoing development and construction of NSE's solar PV generating portfolios in assigned regions. As an important member of the operations team, y ...
Senior Digital Demand Manager, CRO

3 weeks ago

OwnBackup Englewood Cliffs, United States

Own is the leading data platform trusted by thousands of organizations to protect and activate SaaS data to transform their businesses. Own empowers customers to ensure the availability, security and compliance of mission-critical data, while unlocking new ways to gain deeper ins ...
IT Project Manager

2 weeks ago

Eliassen Group Plainfield, United States

Our World Class Client (or Eliassen Group) is seeking an IT Project Manager to have single point accountability, or can possibly be under the general direction of a Project Director or Senior PM. The Project Manager I (PM-I) position is responsible for the management, or the assi ...
Senior Project Manager

3 weeks ago

Nautilus Solar Energy Summit, United States

Job Description · Job DescriptionSenior Project Manager · Position Summary · The Nautilus Solar Energy Senior Project Manager will be responsible for overseeing the ongoing development and construction of NSE's solar PV generating portfolios in assigned regions. As an important m ...
Senior Project Manager

2 weeks ago

Georgia IT Inc Berkeley Heights, United States

Job Title: Senior Project Manager · Job Location: Berkeley Heights, NJ or Alpharetta, GA-Hybrid · Employment Type: RTH 6 months · Job Responsibilities: · Manage IT cross-functional teams, project timelines, and cross-project dependencies to ensure acceptable delivery by the Cli ...
Project Manager

2 days ago

Diverse Lynx Madison, United States

Project Manager · Madison - NJ · Job summary Should have extensive experience in Data warehousing projects using MDM, Oracle and Unix · Minimum of 6 years of experience in MDM is mandatory and a basic requirement Experience in Support process is an added advantage · Must have ha ...
Construction Project Manager

4 hours ago

iWorld Professionals Springfield, United States

iWorld Professionals is seeking a Construction Project Manager for our client in Springfield, NJ. If you are interested in working for a well-established construction company that is a leader across many industries, serving clients throughout the northeast US, then this is the po ...
IT Project Manager

1 week ago

Eliassen Group Plainfield, United States

Job Description · Job Description**Hybrid in Plainfield, IN.** · Our utilities client is looking for an IT Project Manager to join their team. · Due to client requirement, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits ...
Project Manager for IT Engineering Projects

1 week ago

Radiant Innovations Free Union, United States

About the Company · We are an innovative software manufacturer with 28 employees in computer science and business expertise, with locations in Hamburg, Bangkok, and Los Angeles. · We develop electronic scheduling software in the B2B sector for resource-oriented job planning in co ...
Project Manager

1 week ago

Nexus Innovations Ridgewood, United States

PLANSITE integral design & engineering is part of the Brüninghoff Group, which aims to become a pioneer in the construction industry in Europe with its more than 700 employees at 7 locations. Projects like H7 and HAUT are just the beginning. Through the use of integral planning p ...
Project Manager-Application Development

4 weeks ago

Ask Staffing Summit, United States

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment". · Job Title: Project Manager-Application Development · Location: Summit West, NJ Remote) · Duration: 12 months · Pay r ...
Project Manager

1 week ago

Crimson Ventures Packanack Lake, United States

About heo GmbH: · Welcome to heo. Since its inception, our team at heo has developed the company into a leading international player in the world of pop culture. · A deep-rooted passion has been the driving force behind our work from the very beginning. It means a lot to us to co ...
Project Manager

1 week ago

Apex Dynamics Amboy, United States

Is there a logistics for careers? With us, there is. As a globally operating logistics service provider with employees in over 60 countries, we manage complex supply chains and offer our customers innovative additional services. Rhenus Warehousing Solutions is one of the leading ...
Project Manager

1 week ago

Omega Innovations Elmhurst, United States

Your role with us: · Independent and success-oriented project management of our construction projects · Invoice verification and warranty management · Collaboration with architects, specialist engineers, authorities and subcontractors · Technical support in execution planning ...
Project Manager

1 week ago

Sapphire Solutions Cove, United States

Join us in shaping the future together: That is the guiding principle of the pro-beam Group. We are one of the world's leading companies in the field of electron beam technology and operate in a complex technological environment - from welding to additive manufacturing. With our ...
Information Technology Project Manager

2 weeks ago

Eliassen Group Plainfield, United States

Plainfield, IN | IT Project Manager | 2-3 days onsite · The ideal candidate will be responsible for designing, implementing, managing, and evaluating IT projects across our organization. In order to do this successfully, this person should feel comfortable handling multiple tasks ...
Project Manager

1 week ago

Horizon Ventures Closter, United States

At Closter, VINCI Energies provides tailored complete solutions in the field of Building Solutions. Our companies offer services in the areas of Design & Build, technical maintenance, and building management, covering the entire life cycle of a building. DECHOW is part of this ne ...
Project Manager

2 days ago

Matrix New World Florham Park, United States

We are currently seeking a motivated individual who desires a challenging career and increasing responsibilities as a Project Manager - Civil Engineer. · Key Responsibilities: · Perform engineering tasks in the civil/structural engineering field through the development of a work ...
Project Manager

4 weeks ago

Ask Staffing Summit, United States

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment". · Job Title: Project Manager · Location: Summit West, NJ Remote) · Duration: 12 months · Pay rate: $128.57/hr. on ...
Project Management

1 week ago

Fiserv Berkeley Heights, United States

Calling all innovators - find your future at Fiserv. · We're Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations, merchants, and consumers to one another millions of tim ...