Cannabis jobs at Clinical Research Strategies

Clinical Research Strategies (CRS) is a virtual, boutique CRO and executive management consultancy for the life science industry. Founded by industry veterans with corporate compliance, business operations, regulatory affairs, quality assurance, clinical operations and project management expertise, we are seeking a Project Management Director (PMD) to augment our team and growing business.

Fundamental to our approach is a culture that cultivates trust and embraces diversity, empathy, leadership, entrepreneurship, mentorship, high-performing teams, and objective moral and ethical values, that prioritize our staff. Review our corporate policies here: http://www.clinicalresearchstrategies.com/policies.html

We help US, Canadian, Asian, and European life science companies bring novel medical products to market in new and emerging indications, including: regenerative medicine, orthopedics, immunoncology, precision medicine, respiratory, critical care, women’s health, urology, infectious diseases, pain (cannabis), CNS (Alzheimer’s, concussion), neurostimulation, and electrotherapy.

Our core services are: participating in federal and international grants, providing agile teams for functional service models, quality management systems, FDA negotiations and strategy, clinical development plans, product roadmaps, CRO audit, selection and due diligence, EU-MDR Literature Reviews and Clinical Evaluation Reports (CERs), corporate start-up, digital health, SaMD, blockchain, and more. Our work is also in biologics, drugs, combination products, IVDs/diagnostics (CLIA), and medical devices (Class II – III).

All staff work from their home office with occasional travel to clients or to the FDA campus. FTE or contract to hire opportunity.

Project Management Director (PMD)

1. Summary

The Project Management Director (PMD) will be responsible for overseeing and managing client programs CRS under best business and ethical practices, and applicable regulations including current Good Clinical Practices (GCPs) and ISO14155. This role is autonomous and involves the highest level of critical-thinking, flexibility, teamwork, and client relations. The PMD owns the client relationship for the duration of a project.

2. Duties, Activities, and Responsibilities

2.1 Adherence to US laws and regulations, business ethics, corporate and financial compliance, confidentiality, and industry-wide best practices

2.2 Facilitation of contracts, monthly/milestone invoicing, and payments

2.3 Production of SOPs, RFPs, gap analyses, TMF audits, written policies, regulatory positions, presentations, training programs, and white papers

2.4 Presentation of capabilities and bid defenses to prospects and clients

2.5 Conduct upfront and routine risk analyses to proactively identify program risks

2.6 Collaboratively implement risk mitigation strategies to ensure successful delivery of program goals

2.7 Provide oversight for development and implementation of project plans in accordance with SOPs and regulations

2.8 Contributions to strategy for IND- and IDE-enabling drug and device products, submissions, and clinical trials

2.9 Preparation of fair market budgets (FMV) and realistic forecasts with disciplined spend

2.10 Application of GxP regulations and requirements to projects

2.11 Quality-driven management and oversight of vendors and CROs

2.12 Perform research for and participate in capability presentations of technology provider innovations that reduce costs to clients

2.13 Follow FDA, EU, ICH-GCP, and ISO regulation changes

2.14 Creation of electronic files and maintenance of documentation in a regulatory-compliant and cyber-secure environment

2.15 Interface with regulatory officials, investors, business partners, and client executives

2.16 Management of client relationship management (CRM) system

2.17 Spearhead projects to completion

2.18 Creation of routine status reports for clients

2.19 eTMF and paper TMF expertise, set-up, oversight, audits

2.20 Serve as lead Project Manager for Sponsors, CROs, and CRS when needed

2.21 Oversee project management and project manager activities for clinical trial programs

2.22 Define program requirements and timelines

2.23 Conduct feasibilities

2.24 Recruit, screen and interview talent for clients

2.25 Recruit and train CRAs

2.26 Obtain quotes of insurance for clients

2.27 Create RFPs for Sponsors undergoing CRO selection

2.28 Prepare meeting minutes or notes

2.29 Assist with business operations

3. Education and Experience

3.1 Advanced degree required with 8+ years of industry experience.

3.2 5-10+ years of experience with project management in life science industry.

3.3 Experience writing protocols, informed consents, protocol-related documentation, proposals, quotes, business plans, SOPs, policy, capability presentations, bid defenses, and gap analysis.

3.4 Critical thinking, problem-solving, and fact-finding.

3.5 Regulatory review and writing.

4. Knowledge, Skills, and Abilities

4.1 Required thorough understanding and knowledge of documentation, records management, and regulatory conformity in support of GCP regulations and best business and ethical practices.

4.2 Demonstrated ability to communicate effectively (verbal and written) across cross-functional divisions and vendors internally and with key clients and stakeholders externally.

4.3 Proven ability to lead the initiation of clinical research programs and building of quality results over the life of a clinical trial.

4.4 Expert at time management and deliverables.

4.5 Expert at presentations to wide audiences.

4.6 Medical device, oncology, precision medicine, and regenerative medicine experience preferred.

4.7 NIH, NCI, and DoD grant experience preferred.

4.8 Proficiency in software applications such as Outlook, Word, Excel, Visio, PowerPoint, Project, SharePoint, etc.

Job Types: Full-time, Contract

Salary: $85,000.00 to $115,000.00 /year

Experience:

• Clinical Research: 8 years (Required)
• Project Management: 8 years (Required)

Education:

• Master's (Required)

Work authorization:

• United States (Required)

Contract Length:

• More than 1 year

Full Time Opportunity:

• Yes

Work Location:

• Fully Remote

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By clicking the "Apply now" button, you'll be leaving Fazow and going to an external job application page for this company. Please research all companies before applying. When applying for jobs, you should NOT have to pay to apply. Fazow accepts no liability or responsibility as a consequence of any reliance upon information on external sites or in jobs listed on fazow.com.

Clinical Research Strategies (CRS) is a virtual, boutique CRO and executive management consultancy for the life science industry. Founded by industry veterans with corporate compliance, business operations, regulatory affairs, quality assurance, clinical operations and project management expertise, we are seeking a Project Manager (PM) to augment our team and growing business.

Fundamental to our approach is a culture that cultivates trust and embraces diversity, empathy, leadership, entrepreneurship, mentorship, high-performing teams, and objective moral and ethical values, that prioritize our staff. Review our corporate policies here: http://www.clinicalresearchstrategies.com/policies.html

We help US, Canadian, Asian, and European life science companies bring novel medical products to market in new and emerging indications, including: regenerative medicine, orthopedics, immunoncology, precision medicine, respiratory, critical care, women’s health, urology, infectious diseases, pain (cannabis), CNS (Alzheimer’s, concussion), neurostimulation, and electrotherapy.

Our core services are: participating in federal and international grants, providing agile teams for functional service models, quality management systems, FDA negotiations and strategy, clinical development plans, product roadmaps, CRO audit, selection and due diligence, EU-MDR Literature Reviews and Clinical Evaluation Reports (CERs), corporate start-up, digital health, SaMD, blockchain, and more. Our work is also in biologics, drugs, combination products, IVDs/diagnostics (CLIA), and medical devices (Class II – III).

All staff work from their home office with occasional travel to clients or to the FDA campus. FTE or contract to hire opportunity.

Project Manager (PM)

1. SummaryThe Project Manager (PM) is responsible for leading the management of clinical trials from study start-up to completion and based upon CRS’ contracted services with a client. The PM will help ensure the clinical trial is conducted in compliance with applicable regulations including current Good Clinical Practices (GCPs). The PM is also responsible for project management of non-clinical trial work.

2. Duties, Activities, and Responsibilities

2.1 Managing and coordinating cross-functional project teams.

2.2 Serving as the primary project contact with the client.

2.3 Monitoring team performance against the contract, client expectations, and project milestones.

2.4 Leading problem-solving and resolution efforts to include management of risks, contingencies, and issue resolution.

2.5 Leading study kick-off, site engagement and credentialing, contracting and trackers.

2.6 Developing study management plans, together with team assignments and responsibilities.

2.7 Developing study budgets under fair market value analysis.

2.8 Assisting with data integrity, data query and resolution issues.

2.9 Assisting with the collection and maintenance of Essential Documents.

2.10 Facilitating site payments.

2.11 Facilitating on-going communications with the investigational sites.

2.12 Assisting with software specifications and participating in user acceptance testing of EDC.

2.13 Collaborating with vendors and managing their performance.

2.14 Providing oversight of database maintenance, trial master file (TMF), and study trackers.

2.15 Developing meeting minutes and sign-off records.

2.16 Preparing and reviewing expense reports with adherence to CRS or client Travel Policy.

2.17 Ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.

2.18 Assisting Quality Assurance with CAPAs, SOP revisions, audits, and inspections.

2.19 Project management of other non-clinical trial projects.

3. Education and Experience

3.1 A Bachelor’s degree or equivalent in a life sciences or related discipline.

3.2 Ideally five to eight years of clinical research experience with increasing responsibility.

3.3 Alternatively, equivalent combination of education, training and experience in a life science environment.

4. Knowledge, Skills and Abilities

4.1. Ability to meet deadlines for project team, Client, and vendors.

4.2. Continuous learning and training on ICH GCP, FDA, ISO, and international regulatorypositions and updates.

4.3. Excellent professional written and verbal communication skills.

4.4. Excellent time management skills and attention to details.

4.5. Proven ability to be flexible and adaptable.

4.6. Ability to maintain relationships for repeat business.

4.7. Ability to write and modify SOPs, CAPAs, work instructions, forms, and templates.

4.8. Proficiency in software applications such as Outlook, Word, Excel, Visio, PowerPoint, Project,SharePoint, etc.

4.9. Demonstrated understanding of medical terminology and knowledge in therapeuticareas.

Job Types: Full-time, Contract

Salary: $75,000.00 to $85,000.00 /year

Experience:

• Clinical Research: 5 years (Required)
• Project Management: 5 years (Required)

Education:

• Master's (Required)

Work authorization:

• United States (Required)

Contract Length:

• More than 1 year

Full Time Opportunity:

• Yes

Work Location:

• Fully Remote

Apply for this job with Clinical Research Strategies

Apply now →

By clicking the "Apply now" button, you'll be leaving Fazow and going to an external job application page for this company. Please research all companies before applying. When applying for jobs, you should NOT have to pay to apply. Fazow accepts no liability or responsibility as a consequence of any reliance upon information on external sites or in jobs listed on fazow.com.