Description

Job Description

Responsibilities

As a CTM you will come to the Los Altos office and act as a vital contributor to fostering our client's culture, ensuring accountability, and managing daily clinical team operations.  With this company, you will collaborate with the management team to translate their clinical strategy into actionable short-term plans and ensure their successful execution to meet their annual and long-term corporate goals.  This position is suited for someone well-versed in the dynamic clinical landscape, capable of immediate action, and adept at identifying and addressing issues.  

• Hands on CTM with a keen ability to manage all aspects of clinical development.
• Have command over submissions and communications with IRBs and ECs 
• Create study/program milestones with well-developed tracking and reporting.
• Work with minimal supervision and open to people management and training.
• Have a strong understanding and ability to manage multi-center oncology trials.
• Create and complete Informed Consent Forms (ICFs), protocols and amendments, Investigator's Brochure (IB), site budget and Clinical Trial Agreement (CTA), and make valuable contributions to IND submissions

Qualifications

• Bachelor's degree, RN or equivalent
• Minimum of 6-8 years of experience in clinical research; oncology experience preferred.
• Demonstrates strong analytical, technical, and project management skills, excelling under pressure and juggling competing priorities.
• Highly experienced with senior executives in both large pharma and emerging biotech. A resourceful, strategic, and analytical thinker, skilled in shaping future company strategy, anticipating challenges, and devising successful solutions.

Description

Job Description

Our Client is seeking a Laboratory Assistant to work with a Comparative Medicine team that prioritize animal welfare, employee safety, and operational efficiency. These services create an internal clinical environment for research, development, and training. The Comparative Medicine team also aids in the swift development and improvement of products and procedures.

Responsibilities

The ideal candidate will have the responsibility to perform moderately complex technical tasks and provide operational support in various clinical research and training areas. This includes ensuring compliance with federal, state, and local standards, as well as governmental regulatory requirements within Comparative Medicine operating rooms and training labs, all under limited supervision. This is an excellent opportunity for personal growth and deep insights into clinical research. This role will combine Vet Tech Duties and Lab Ops Duties

• Stay "inspection ready" and join audits for compliance
• Help plan daily activities and set up for the next day
• Identify/reprocess advanced instrumentation
• Train entry-level team members
• Participate in regulatory audits
• Ensure radiation safety
• Handle additional tasks for lab logistics with oversight
• Perform other duties as needed to support the company's strategy and goals

Qualifications

• HS diploma, AS preferred (vet tech programs, biology, animal science preferred). OR prior experience in animal setting (lab animal or clinic) including giving IM injections, placing catheters and anesthesia experience.
• Contractors may be converted after filling internal requirements for the client.
• Excellent written and verbal skills with the ability to work well with stakeholders.
• Promote animal welfare demonstrate commitment to personal responsibility and value for animal welfare; communicate concerns.
• Must be able to lift/carry 50 lbs and wear protective equipment.
• May be exposed to radiation or electromagnetic fields, lasers, noise  80dB TWA, allergens/biohazards/chemicals (cautery smoke).

Description

Job Description

The Senior Clinical Data Manager (Sr. CDM) is responsible for data management activities across multiple studies. The Sr. CDM will report to the Manager, Clinical Data Management and will work closely with a cross-functional team in a fast-paced environment. The Sr. CDM is responsible for leading the end-to-end data management activities and associated deliverables for clinical trials, including study set-up, conduct and close-out, standards development and GCP compliance.

Responsibilities

This is a direct, hands-on role and the main requirement is to perform, as well as manage, all day-to-day data management activities. Other responsibilities include, but are not limited to:

• Create, review and approve all data management study-related documents, which may include, but not limited to: eCRF/Database specifications, Edit Check specifications, Data Management Plan (DMP), UAT Plan Data Review Plan (DRP), CRF Completion guidelines, Coding Convention guidelines and other documentation as required.
• Perform and manage all data cleaning activities including processing queries, performing ongoing data review, and orchestrating scheduled cross-functional data review/reconciliation, identifying issues, data trends and tracking them through resolution.
• Perform and manage all database build activities, database validation and review and execution of User Acceptance Testing (UATRepresent Data Management in internal study team, client and CRO meetings.
• Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to manager any requested out of scope activities.
• Work with outside vendors (such as safety laboratories, cardiac laboratories) to develop data transfer documents and perform regular data reconciliation with the clinical database.
• Assist DM oversight role/manager in monitoring timelines and managing resources to meet timelines. 
• Identify inconsistencies and inefficiencies in data management processes and recommend solutions. 
• Have a thorough understanding of the study billing guide, manage expectations with the support Clinical Data Manager(s) on the assigned tasks, available hours, and keep the billing guide current. 
• Forecast hours available against study activities and o Assess if the study activities are in scope per the approved budget
  Work with the DM oversight role/manager in the change order process and ensure an approved change order is in place for any out-of-scope work.
  Enter and verify the time spent on the project and non-project work on InClin's time tracking tool regularly (daily time entries preferred, weekly at the minimum). 
• Direct team members in daily activities, including training and supervising study support staff.
  
  

Qualifications

o 9+ years data management experience and B.S./B.A. in a science or technical discipline degree. o Previous CRO experience is strongly recommended.
o Proficient in MS Excel. o Ability to program in SQL or SAS desirable, but not required. o Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes. Medidata Rave EDC, Medrio eClinical and Clario EDC experience are preferred, but not required.
o Excellent oral and written communication skills.
o Ability to work in a collaborative and multi-disciplinary environment.
o Attention to detail, ability to prioritize and manage multiple projects with competing and aggressive timelines.
o Availability to travel for clinical team meetings and/or Investigator Meetings if needed.
o Good knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonisation (ICH) guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

Description

Job Description

Responsible for analyzing financial information primarily cash, inventory and working capital (AR and AP), in order to facilitate accurate and timely reporting to Finance Leadership and the Senior Leadership Team/Board of Directors. Ensure appropriate accounting control procedures and compliance with all debt agreements, interest and other cash related agreements. Expected to work cross functionally to develop and implement methodologies and practices to achieve compliance and maintain financial statements and related accounting records. The Manager will utilize their knowledge of Finance and Treasury to enhance our Cash Conversion Cycle (CCC), manage cash, increase interest income and minimize interest expense, while ensuring proper and timely reporting compliance.

Essential Duties & Responsibilities

Responsible for managing multiple accounting functions including but not limited to:

• Treasury / Cash management analysis and reporting including Daily Cash Balance Reporting and weekly 13-week Cash Forecasting updates
• Banking and debt compliance reporting
• Working capital review, alignment and improvements
• Inventory review and reporting including inventory reserve requirements
• Documentation of various system and process enhancements
• Cash interest management
• Oversee/Manage Accounts Payable processes and improvements from WC perspective
• Oversee/Manage Accounts Receivable processes and improvements from WC perspective
• Create clear, easy to use and updated templates related to cash forecasts and working capital for financial packages for internal reviews and board presentations, for all of Cosette businesses and sites
• Support the planning and execution of the entire organization for cash flow projections and analysis of planning, budgeting, and forecasting cash flow process, assuring quality and integrity of data
• Assist in the develop of the 5-year Strategic Plan, including development of working capital projections and cash flow projections for forecast models and performance metrics
• Assist with balance sheet and cash flow analytics related to evaluating potential Business Development opportunities
• Support accounting team with external auditors to ensure timely completion of annual financial audit
• Liaise with Supply Chain (including CMO's), Operations / Quality, Technical Services and Business Development to ensure the accounting impact of all activities is properly recorded in a timely manner
• Month-end financial closing activities

•     Critically evaluate processes, implementing new/revised processes and procedures to help improve the organization

Qualifications

o Bachelor's degree in Accounting, Finance or Economics, MBA a plus
o 4-7 years of progressive Finance/Accounting/business experience
o Pharmaceutical experience preferred
o Prior supervisory experience a plus
o Prior experience in manufacturing environment preferred
o Ability to manage multiple projects and deadlines with a high degree of accuracy and attention to detail
o Results driven self-starter, who can work independently or with minimal supervision and who has success in a team environment
o Demonstrated ability to work and communicate effectively in a cross-functional environment
o Strong supervisory skills
o Attention to detail and accuracy
o High degree of proficiency with Microsoft Excel, PowerPoint and Word
o ERP experience required (Oracle experience a plus)
o Pharmaceutical industry knowledge is a plus

Description

Who we are:

Bevov is building a platform to connect BioPharma professionals with interesting opportunities within the BioPharma industry without having to search for them. We have the largest network of BioPharma companies who are looking to connect with the right candidate without having to go through the hurdles of multiple job applications and not getting to hear back from them. Our platform's goal is to provide a positive candidate experience by companies showing interest in you instead of you applying to them, matching you with the right job with competitive and flexible compensation, and helping you through the interview process via our platform and SuperRecruiters.

Responsibilities

Qualifications

Description

Job Description

Responsibilities

Qualifications

• Valid and active Registered Nurse (RN) license in NY
• Minimum of 2 years of recent experience in home care nursing
• Demonstrated proficiency in conducting comprehensive patient assessments and developing effective care plans
• Strong clinical skills, including medication administration, wound care, and IV therapy
• Excellent communication and interpersonal skills, with the ability to connect empathetically with patients and their families
• Sound judgment and critical thinking abilities in managing complex patient situations
• Proficiency in electronic medical record (EMR) systems and basic computer skills
• Valid driver's license and reliable transportation for home visits

Description

Job Description

Our Client operates a vast network of approximately 5,000 healthcare providers who reach out to individuals in diverse settings to assess their health and safety, identify and bridge gaps in care, and deliver life-changing services that empower them to take control of their well-being. By delivering expert care and healthcare solutions, our Client serves millions of individuals at risk, right in their own communities.

Responsibilities

• Perform screenings including medical history, physical exam, medication reconciliation and education
• Effectively identify, evaluate, and address the concerns of the member, employee, or participant
• Administer and order point-of-care and lab-based testing
• Order and interpret diagnostic imaging and laboratory results and provide clinically appropriate interventions, additional tests, or referrals as needed
• Refer members to PCP, case management, disease management programs, and applicable specialist as necessary
• Maintain positive control of all PHI information and compliance with OSHA and the State Board of Nursing

Qualifications

• Valid Nurse Practitioner (NP) certification/license in California (CA)
• Valid Physician Assistant-Certified (PA-C) certification/license in California (CA)
• Comfortable performing In-Home health assessments
• Must be Covid-19 vaccinated.
• Having NP/PA License Number is preferred.

Benefits

• Medical, Dental, Vision, 401K, PTO, Company paid holidays, Life Insurance, and Mileage.

Description

Job Description

Our client is a growing biotech company based in Rochester, Minnesota. Our mission is to provide innovative solutions to support viral, gene, and cell therapies to improve the quality of life for patients worldwide. We are a leading provider of contract research services with a focus on oncolytic virus therapies, virus and cell engineering, and custom laboratory assay development. We have a diverse team of intellectually and technically skilled virologists, immunologists, molecular biologists, and assay development scientists, who work together closely to build upon each other's strengths and deliver timely best-in-class results. We are looking for a Research Technologist to join our dynamic team.

Responsibilities

Qualifications

o Bachelor's degree with a minimum of one year of laboratory research with cell culture OR Master's degree having laboratory research with cell culture.
o Must have experience in molecular cloning.
o Must have experience in working with various mammalian cell lines.
o Must have experience in CRISPR/TALEN.
o Must have experience with eukaryotic cell culture.
o Ability to plan, organize, and multi-task to complete assignments in an efficient manner.
o Ability to work independently and as part of a team.
o Excellent attention to detail and organization.

Benefits

Description

Job Description

Our client is a US-based diversified branded and generic pharmaceutical company specializing in women's health, dermatology, and allergy, with products available in dosage forms such as creams, ointments, lotions, solutions, gels, pastes, and suppositories. It is a diversified pharmaceutical company with end-to-end Product Development, Manufacturing, and Commercial Operations capabilities. With well-established R&D and Business Development, functions company is expanding its product offering by bringing new products to market via internal development and external licensing or acquisitions. While staying true to its therapeutic history, it is expanding into adjacent areas.

Responsibilities

• Review returns claims and determine credit to be allowed, following customer contracts and return policies.
• Maintain accurate data in internal and returns service provider systems for timely and precise returns processing.
• Collaborate with the Customer Service team to address and process failure to supply and service level penalties claims.
• Process claims in the system and ensures customers receive the appropriate credits.
• Serve as the primary contact for internal teams and customers regarding returns, FTS, and SLP credits inquiries.
• Assist the Accounts Receivable team in resolving claims variances and developing resolution plans.
• Communicate issues to the Manager and take the initiative to resolve them.
• Assist in data requirements and other analysis projects.
• Develop a strong understanding of contracting terms, returns lifecycle returns credit pricing, and system setups.
• Actively participate in system enhancement projects.

Qualifications

• Bachelor's degree in Accounting, Finance, or related business field.
• Minimum of 2-4 years of relevant experience.
• Strong computer skills, including knowledge of financial applications, ERP packages, and GTN Operations.
• Excellent written and presentation skills, with strong interpersonal and team-building capabilities.
• Self-starter with the ability to prioritize and manage multiple responsibilities simultaneously.
• Dependable and confident in own abilities.
• Strong drive, dedication, and work ethic.
• Team-oriented with a willingness to contribute.
• Open communicator and inquisitive.
• Strong organization and problem-solving skills.
• Detail-oriented and process-oriented.
  
  

Description

Job Description

Our client is a full-service Clinical Research Organization (CRO), a leading provider of Clinical research services & mission is Science with Integrity. It has fifteen years of impeccable regulatory history & has accumulated expertise in Early Phase (BA/BE), First in Man, Late Phase (various therapeutic areas), Respiratory, Tobacco Research, Dermatology, Consumer Research, Analytical lab, Diagnostic Central lab, IVRT, IVPT, Biometrics, Environmental Exposure Chambers, Pharmacovigilance and Medical Services.

This role is Full Time, permanent, Regionally Home Based position with around 70 to 75% travel from Apr 2022 Onwards (Based upon COVID-19 travel restrictions)

Responsibilities

• Prepare or submit or support other colleagues for Regulatory and EC submissions and in the generation of Financial Agreements according to standard and local country practices.
• Conduct monitoring visits as per the monitoring plan in order to check compliance with study management, protocol & other requirements at all assigned sites. Responsible for training of site study team regarding the monitoring plan, recording & maintenance of essential documents, and for startup activities & site initiation as per the guidance of Project Manager.
• Assist in the preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures.
• Maintaining a working copy of the Central Investigator File & ensuring consistency with the Site Investigator File in order to maintain a working record of all essential documents and reports.
• Perform source document verification as per monitoring plan and ensure that source documents & other trial records are accurate, complete, kept up-to-date & maintained according to applicable SOPs to avoid incomplete records.
• Ensure timely collection of documents like CRF, DCF, etc. from the site along with SAE reports in order to provide Biometrics/licensing authority & others with the necessary documents.
• Responsible for study updates & Coordination with Labs & other trial-related services as per the study requirements.
• Responsible for IP accountability and availability, tracking and management of all Clinical Trial related supplies shipped to the sites/ warehouse & accordingly clinical trials supplies vendor management for the study.
• Ensure proper escalation of site/project-related issues to the Project Manager/ Designee in a timely manner.
• Responsible for site-closeout & follow-up activities in order to maintain documents at the site.
• Attend staff meetings and training sessions as required to complete the training curriculum in a timely manner.
• Assist with the audit of an investigational site or central files and liaise with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP and applicable regulatory guidelines.
• To liaise with other departments within the organization for timely achievement of the project milestones.
• Ensure to follow and adhere to organizations' general rules, policies, and applicable SOPs.
• CRA will review the study feasibilities and assist the PM in preparing the feasibility report/ tracking

Qualifications

• Bachelor's degree in life science or related field of study or equivalent combination of studies, and/or work experience
• 2+ years relevant experience, including substantial monitoring experience KNOWLEDGE
• In-depth knowledge of ICH-GCP guidelines, and applicable regulations, rules, and guidance, as applicable
• Keeps abreast of regulatory requirements and scientific knowledge and maintains technical expertise by reading relevant publications, attending courses, and through membership in relevant industry/professional associations SKILLS
• Proven IT proficiency and skills including Microsoft Office
• Effective problem solving, time management, and organization skills
• Effective verbal and writing skills; English and local language, if relevant
• This position requires the ability to perform varied tasks, maintain an appropriate work pace, exercise logic and reasoning, and comprehend and follow instructions
• This position requires the ability to travel 70 - 75%
  Performing the duties of this job regularly involves speaking and listening, repetitive hand movement (at least 15 minutes), and sitting for long periods of time; involves some standing, walking, grasping, reaching and lifting of up to 10 pounds