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$69k–$104k/yr
Full-time
bachelor degree
Discretionary Annual Bonus, Health Insurance, Retirement Savings Benefits, Life Insurance, Disability Benefits, Parental Leave
Posted 10d ago
~40 hrs/week
Remote in United States
Responsibilities
Review, draft, and negotiate various legal agreements including CDAs and CTAs while managing site budgets. Coordinate with internal study teams and sponsors to ensure deliverables align with project timelines.
Requirements
Requires a bachelor's degree or equivalent experience with at least 3 years of experience drafting and negotiating clinical research agreements. Experience in the biotech, pharmaceutical, or life science industry is preferred.
Full job description
Position Summary: Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents. Will work closely with the Clinical Operations study team and play an administrative role to ensure deliverables are in alignment with defined project timelines and expectations.
Essential functions of the job include but are not limited to: • Prepare and negotiate Agreements/Amendments such as Confidentiality Disclosure Agreements (CDA), Clinical Trial Agreements (CTA) and Amendments (CTA-A), vendor contracts and site budgets. • Lead interactions with the North American and European internal study teams, as applicable • Lead interactions regarding the various agreements with the Site(s) • Lead interactions regarding assigned agreements with the Sponsor(s) • Work with supervisor and various internal/external stakeholders to resolve contractual issues. • Ensure adhered to company policies, procedures, and contracting standards. • Update relevant study team members and sponsors regarding the status of contract negotiations and execution. • Coordinate execution of the agreements • Support the maintenance of contract files and databases, including email and document archiving. • Other duties as assigned.
Qualifications:
Minimum Required: • Bachelor’s degree, or equivalent contract management experience preferably in a clinical research or similar industry setting
Other Required: • 3 years of relevant experience drafting, reviewing and negotiating agreements related to clinical research i.e. Non-Disclosure Agreements, Clinical Trial Agreements, etc. as well as management, control and tracking of the contract process. • Experience in contract research, life science, biotech or pharmaceutical industry is preferred. • Experience interacting with European institutions.
Preferred: • Equivalent contract management experience in a clinical research or similar industry setting • Experience in contract research, life science, biotech or pharmaceutical industry.
Skills: Competencies • Excellent organizational and communication skills and attention to detail • Experience in tracking status for site contracts and budget, filing and distribution. • Executes time-sensitive matters while maintaining accuracy and attention to detail. • Exhibits high self-motivation and is able to work and plan independently or with limited supervision. • Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments and understanding of the service culture and positive interactions with customers. • Proficient in MS Office Software programs and computer applications • Works well independently and cooperatively with others to achieve common goals in a virtual environment. • Develops, maintains and strengthens relationships with others inside or outside of the organization who can provide information, assistance and support Mentor and/or Ambassador for new Contract and Budget Associates and PFM staff
#LI-KH1 #LI-Remote
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$68,700—$103,700 USD
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.
Related keywords
Clinical Trial AgreementsCTACDASite BudgetsContract ManagementLife SciencesBiotechPharmaceuticalClinical ResearchFSPContracting StandardsNorth American InstitutionsEuropean InstitutionsLegal AgreementsPrecision Medicine Group
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One of our core values is giving back. Volunteering at hospitals, supporting life science related fundraisers and partnering with nonprofit organizations is an integral part of our culture. In doing so, not only do we raise awareness of many life-threatening diseases, but we also bring our team and our client’s team closer to the actual patients and families that will be impacted by our work.
Project Farma is a PerkinElmer company. (https://www.projectfarma.com/)
Offices: 710 Bridgeport Ave, Shelton, Connecticut 06484, US
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Project Farma is a patient-focused global leader in advancing technical operations from ideation through commercialization with a proven track record of planning, building, and maintaining manufacturing facilities, capital expansions, and technical operations for complex biologics and novel modalities. We provide end-to-end services for the entire manufacturing lifecycle for pharmaceutical and biotech companies, universities, hospitals, and government agencies. Project Farma has executed 100+ facility builds, retrofits and expansions, managed 400+ large scale capital projects, industrialized 10+ commercial cell, gene, and novel therapies, and managed $6B+ in technical operations capital investments.
One of our core values is giving back. Volunteering at hospitals, supporting life science related fundraisers and partnering with nonprofit organizations is an integral part of our culture. In doing so, not only do we raise awareness of many life-threatening diseases, but we also bring our team and our client’s team closer to the actual patients and families that will be impacted by our work.
Project Farma is a PerkinElmer company. (https://www.projectfarma.com/)
Offices: 710 Bridgeport Ave, Shelton, Connecticut 06484, US
Cleaning Validation Compliance & Quality Assurance Commissioning & Qualification Computer Systems Validation Controls & AutomationEnvironmental MonitoringEngineeringFinancial Strategy Process Validation Program Management