Job Title: Clinical Project Manager (Non-MD) - C Duration: 12 Months Location: Princeton, NJ 08540 OR, Santa Clara, CA 95054
Details: Working with diverse groups such as Regulatory Affairs, Program Management, Research & Development, Quality Assurance and external clinical contractors the primary role of this position is the facilitation and management of APOC’s Clinical Study program.
Worker will be selected to Work in Princeton or Santa Clara
This positions responsibilities include, but are not limited to: • Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations. • Oversees development of clinical documents, including clinical plans, protocols, forms, and reports. • Manages team to prepare for clinical study initiation, execution and close out activities. • Monitors and reports progress of clinical studies and follows up with team members and line managers when issues develop. • Communicates and works with cross-functional teams to resolve issues that arise during clinical studies. • Ensures consistency of clinical study and processes across clinical trials. • Travels as necessary to aid in program facilitation.
Project supports IVD devices, give info on patients health Project Managers will be work on clinical studies for US regulatory Submission 5 yrs experience Required Has experience with IVD Devices Worked on regulatory research Preference with similar BioMed based company Develop protocols and determining studies that need to be run. Regulatory Submissions Overseeing the study Backend activity such as working with analysis and data cleaning
The position requires excellent communication skills, the ability to prioritize and work independently. Exposure to basic Project Management methods, knowledge of statistics would be an advantage as well as experience using the APOC i-STAT or equivalent system.
Qualifications To be considered for this position, you will have the following education, skills, and abilities: • Post-secondary degree or diploma in Life Sciences, Biochemistry/Chemistry, Nursing, or equivalent.. • 5+ years experience in managing clinical studies or equivalent product development programs. Experience in in vitro diagnostic/medical device related studies is an asset. • Knowledge of Good Clinical Practice and regulations governing in vitro diagnostics/medical devices is desirable. • Advanced skills in project planning and management, judgment, decision-making, and problem solving. • Working knowledge of new product development methodologies an asset. • Ability to be creative in achieving objectives while ensuring compliance to regulatory requirements.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $60.11/hr.
