We are currently seeking a full-time Clinical Trial Project Manager. 

Position Responsibilities:

• Coordinate the activities associated with the evaluation, initiation and management of clinical trials.
• Coordinate clinical and regulatory activities with company ex-US offices.
• Lead in the selection and implementation of clinical sites.
• Contribute to the preparation of clinical protocols and amendments.
• Support the preparation and submission of regulatory reports and clinical study reports.
• Provide technical, scientific, and administrative assistance to the department.
• Manage vendors and communicate with sites and others within the company, both in, and outside the department.
• Coordinate the organization of investigator meetings.
• Assist in the design and format of CRFs, study guides and subjects leaflet.
• Track CRO and third party vendor activities.
• Identify, select, and implement clinical sites.
• Coordinate the activities associated with start up and management of clinical sites.
• Ensure budgets, schedules, and performance requirements are met.
• Monitor progress of studies identifying delays and initiation of corrective actions when necessary.
• Perform other duties as required.

General Responsibilities:

• Operate to the highest ethical and moral standards.
• Comply with our policies and procedures.
• Adhere to quality standards set by regulations, and company policies, procedures and mission.
• Communicate effectively with supervisors, colleagues and subordinates. Be committed to team effort and be willing to assist in unrelated job areas when called upon.
• Provide administrative leadership for company and provide knowledge-based expertise in related areas that can be applied to meeting the strategic goals.
• Travel as needed.

Education Requirements / Experience Level:

• RN/BSN or Bachelor’s degree in a clinical or health-related field or in life sciences.  A master’s degree in a clinical or health-related field or in life science is preferred.
• Seven years of experience in monitoring, clinical trials management, and performing data management activities (e.g., data resolution, database lock, etc.) with a CRO, Pharmaceutical or Biotech Company
• At least 3 years of in-house experience with a CRO, Pharmaceutical or Biotech Company and previous lead/clinical trial manager experience. 

Arianne Consulting is a Clinical Research Organization that offers specialized flexible clinical management solutions with expertise through our international clinical/regulatory offices.  At Arianne highly motivated individuals are working as a team to make a significant impact upon our business while progressing in their careers.

We are currently seeking a full-time Clinical Research Associate I / II.

Position Responsibilities:

• Implement and monitor clinical trials in all phases of drug development.
• Conduct pre-study, initiation, routine, and closeout visits and report findings in a site visit report.
• Act as primary contact to sites.
• Conduct quality assurance activities to assure the compliance of company SOPs, FDA and ICH guidelines of contract research organizations, study coordinators, investigators, and independent consultants.
• Communicate with sites, clinical vendors, and others within the company, both in and outside the department.
• Review and resolve discrepancies in clinical data at clinical sites and central laboratories via query process. 
• Adhere to company SOPs, FDA regulations and ICH guidelines. 
• Track clinical data, regulatory documents, patient enrollment, and data resolutions to assure the timely completion of clinical studies. 
• Provide technical and administrative assistance to the department. 
• Identify and assist in the selection and implementation of clinical sites. 
• Select, design and implement the data collection method and tools with vendors. 
• Assist in the creation of informed consents, case report forms, instruction manuals, Newsletter, and monitoring and tracking tools. 
• Oversee delivery and shipment of clinical trial supplies and ensure accounting of usage in clinical studies.
• Perform clinical finance duties (site payments, CRO payments etc.)
• Perform other duties as required.

Education Requirements / Experience Level:

• Requires a Bachelor’s degree in a life science or RN/BSN degree, or equivalent.
• Two years of experience in monitoring, clinical trials management, and performing data management activities (e.g., data resolution, database lock, etc.) with a CRO, Pharmaceutical or Biotech Company.
• Must have excellent organizational skills and be a team player.
• Must be able to prioritize and function independently.
• Knowledge of FDA regulations and GCP required.
• Computer proficiency required.
• Must be willing to travel.
• Requires excellent verbal and written communication skills

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Arianne Consulting is a Clinical Research Organization that offers specialized flexible clinical management solutions with expertise through our international clinical/regulatory offices. At Arianne highly motivated individuals are working as a team to make a significant impact upon our business while progressing in their careers. We offer an excellent benefits package, which includes medical, dental, vacation and holidays.

We are currently seeking a full-time (part-time to be considered) Drug Safety Associate.

Job Description

The Drug Safety Associate will be working independently to establish work priorities and direction. The Drug Safety Associate will be responsible for evaluating adverse event data received from clinical trials. By working with investigative sites, the Drug Safety Associate will review initial adverse event reports and follow-up with clinical site staff to resolve queries and develop case narratives. The Drug Safety Associate will work closely with clinical data management teams to ensure timely and compliant processing and reporting of adverse events to regulatory authorities as appropriate.

The candidate should have basic knowledge of US and international regulations surrounding the processing and reporting of adverse events. A detailed knowledge of or the ability to learn detailed knowledge of all AE processing functions is required. A demonstrated ability to work within defined departmental standards, computer literacy, and a demonstrated ability to learn new software applications.

General Responsibilities

• Operate to the highest ethical and moral standards.
• Comply with our policies and procedures.
• Adhere to quality standards set by regulations, and company policies, procedures and mission.
• Communicate effectively with supervisors, colleagues and subordinates. Be committed to team effort and be willing to assist in unrelated job areas when called upon.
• Travel as needed.

Education Requirements/Experience Level

• B.S.N. (R.N.) or B.A. or B.A./B.S./M.S. (Life Science) or R.Ph. or Pharm.D.
• At least 2 years of pharmacovigilance experience.
• Candidate should have familiarity with safety regulatory guidelines/references, how to assess them, and when to refer to them; aggregate report, e.g. Periodic Safety Update Report (PSUR), Periodic Adverse Drug Experience Report (PADER) experience, i.e., assemble and write.
• Candidate must provide scientific and technical (including medical writing) support to the Global Pharmacovigilance Product Safety Physicians and Safety Scientists for all aggregate safety reports, including responses to ad hoc queries regarding safety issues, preparation of aggregate reports, ad hoc reports, and safety sections of package inserts.
• Position requires an understanding of clinical data management in relation to assessing clinical trial and safety data.
• Also requires analysis and interpretation of safety issues arising from clinical trials or post-marketing surveillance.
• Knowledge of computer applications and project planning skills.
• Ability to work independently.
• Good interpersonal skills to manage new and ongoing relationships with sites, investigative sites and clients.
• Proficiency in MS word, excel, access and outlook
• Strong attention to detail in composing materials establishing priorities scheduling and meeting deadlines.

Job Description

This position is responsible for supporting the implementation and maintenance of the Document Control and QA training development systems and ensuring compliance to applicable regulatory, FDA, and ICH guidelines/regulations.

This position also supports reviews regulatory and clinical documents, as needed.

Responsibilities include, but are not limited to:

• Ensure correct and timely implementation of document change control requests.
• Review change control documentation for consistency and completeness.
• Communicate with appropriate departments to ensure changes are well documented.
• Receive, review and format documents in preparation for the review and approval process.
• Support document distribution and maintenance (release and archive).
• Perform general word processing tasks. Check format and conformance to document style and standards.
• Support the development, implementation and maintenance of hardcopy and electronic tools necessary to track document control activities.
• Write and revise controlled documents (e.g., SOPs) to support and improve quality systems.
• Support and maintain the controlled document periodic review process.
• File and maintain hardcopy and electronic document/records such that required documentation is retrievable and files are accurate and well organized.
• Create and maintain training records.
• Develop, provide and maintain training systems and tools.
• Train personnel on document format, content, use, control and document control system.
• Assist the Head of QA with the preparation, review, tracking and maintenance of regulatory and clinical documents.

Education Requirements/Experience Level

• Bachelors degree preferred (or equivalent knowledge, skills, experience)
• Experience in Clinical preferred
• 3 to 5 years of pharmaceutical/biotechnology Document Control experience
• 1 to 2 years of implementing training system processes
• Familiarity with regulatory and clinical documents preferred
• Strong organizational skills
• Strong communication skills
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, etc) and Adobe Acrobat
• Attention to detail
• High work ethics

Job Description

This position is responsible for providing QA oversight of Clinical operations, supporting the implementation and maintenance of the Document Control and QA training development systems and ensuring compliance to applicable regulatory, FDA, and ICH guidelines/regulations.

This position also supports the review of regulatory and clinical documents, as needed.

Responsibilities include, but are not limited to:

• Assist with the conduct of routine audits of clinical files to ensure that regulatory documents are collected, updated and filed appropriately.
• Ensure compliance with applicable FDA regulations and ICH guidelines
• Ensure that regulatory and clinical documents are filed, scanned, and archived according to company SOPs, regulatory commitments, and sponsor obligations
• Collaborate with project managers to ensure trial master file content and format are consistent, communicated and adhered to.
• Support the creation, implementation, maintenance and improvement of hardcopy and electronic filing systems for the retention of all clinical trial documents.
• Assist Head of QA with the preparation, review, tracking and maintenance of regulatory and clinical documents.
• Review documentation as needed to support regulatory filings
• Assist with the creation and revision of controlled documents to support and improve quality systems.
• Support, maintain, and improve QA training development systems.
• Provide clinical-specific training to company personnel.
• Assist in training company personnel on other QA aspects, as needed.

Education Requirements/Experience Level

Position Responsibilities:

• Responsible for the development and implementation of business strategies to meet company goals and objectives.
• Support communications projects in the areas of advertising and promotional programs, public relations and trade shows, including Internet-based communications.
• Research and identify potential new clients.
• Assess new business opportunities and generate detailed cost, timeline, scope of work analysis, and develop project proposals.
• Develops, investigates, negotiates, and tracks business agreements.
• Collaborate with Business Team members to plan, develop and evaluate projects by performing market research, determining the project’s financial viability and planning a marketing strategy.
• Works with finance to design cost & pricing models that maximize growth potential of the project.
• Administers and monitors appropriate cost and service measures (budgets, metrics, measures, controls) to ensure the achievement of all key target goals and objectives.
• Negotiates relationships with leading researchers in the field as consultants.
• Responsible for overseeing projects and maximizing project resources.
• Leads efforts to analyze current project operations and makes recommendations for improvement and coordinates the decision-making process.
• Confers with project personnel to provide technical advice.
• Creates and delivers presentations to the Board of Directors and potential corporate investors, venture capitalists, and strategic partners.
• Perform other duties as required.