Job Description
The Director of Clinical Data Manager (CDM) will provide oversight and assist in the coordination in the data management activities from study start-up, data processing, and database close-out for projects where the activities are conducted by CROs.
The ideal candidate will have advanced knowledge of clinical trial processes and be proficient in all aspects of data management from study start-up to study close-out, have experience in Electronic Data Capture (EDC), and experience in the oversight of CROs and 3rd party vendors; in addition, have knowledge of implementing CDISC CDASH CRF Standards and CDISC SDTM/ADaM datasets, have experience in designing and validating clinical trial databases
Responsibilities include, but not limited to:
- Responsible for completeness, timely delivery, and quality of clinical trial data.
- Participate in vendor evaluation, qualification, and selection, as needed.
- Anticipate data management project requirements, institute, and manage appropriate actions to ensure timelines and project goals are met.
- Serve as DM representative at study team meetings and as primary contact for internal departments and external vendors; provide status reports.
- Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other vendors.
- Participate in protocol design/review
- Develop or review Data Management Plans, CRF completion guidelines, edit check specifications, data transfer agreements and other related data management documentation
- Participate in sponsor User Acceptance Testing (UAT) and provide feedback to CRO
- Draft electronic case report forms (eCRFs) specifications and review final eCRFs for completeness and content
- Take a leadership role in sponsor data review for quality issues and general data trends including pre-processing data and collating all comments.
- Review coding and ensure coding is complete and approved by a Medical Monitor.
- Generate output listings for clinical data quality review utilizing the EDC system reports
- Develop and maintain DM SOPs
- Ensure compliance with all applicable laws, regulations, and regulatory guidelines.
- Utilize database and programming knowledge to develop and manage systems for collecting, organizing, and presenting data to define logical outcomes of clinical research
Minimum Skills/Knowledge Required:
- B.S. or equivalent degree (life science preferred).
- Minimum 15-years of relevant pharmaceutical, biotech, or CRO experience in clinical data management, of which some is to include experience in clinical trial database design and data programming.
- Hands on experience with commercially available Electronic Data Capture (EDC) systems
- Proficient computer skills including MS office products (Outlook, Word, Excel), relational databases
- Experience in oversight of CROs and remote project teams
- Experience managing 3rd party vendors
- Understanding of clinical operations, biostats, and regulatory affairs sufficient to perform data management responsibilities.
- Must be proficient in all aspects of data management from study start-up to study close.
- Knowledge of medical terminology and coding processes using MedDRA and WHO Drug.
- Working knowledge of ICH, FDA CFRs, GCP, HIPAA, GCDMP regulations and guidelines, as well as CDISC – CDASH standards, and SDTM/ADaM datasets.
- Oncology experience preferred
- Excellent organizational project management skills with great attention to detail and the ability to multitask.
- Excellent verbal and written communication skills, as well as oral presentation abilities required.
- Excellent interpersonal skills.
- Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments (e.g. Regulatory, Clinical Operations, Clinical Research, CMC, Pre-Clinical, BioStats).
TRAVEL REQUIRED
- Available for minimal travel (<5%) including overnight stays, when required.
- Ability to drive and have a valid driver’s license.
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
EOE
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
About Eiger BioPharmaceuticals, Inc.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Please submit your resume to:
Position Overview
As one of the first colleagues to join the Eiger Medical Affairs field team, you will serve as a founding member of an expanding group that will be critical to the company’s future success. Our MSL field team will be responsible for helping to create and shape the foundation of Eiger’s Medical Affairs initiatives which will include the introduction of our company and our late-stage development programs, with a primary focus on HDV, building a key opinion leader network, developing and maintaining professional relationships with allied healthcare personnel and all external customers, and providing comprehensive medical and scientific support aligned to Eiger development and post approval initiatives. You will work collaboratively with the entire Eiger organization across all functional areas to ensure accurate and appropriate dissemination of information related to our pipeline and therapeutic areas critical to achievement of corporate objectives.
Responsibilities include, but not limited to:
- Develop and maintain scientific and medical expertise in disease states of strategic importance to the Eiger pipeline and corporate objectives;
- Identify, develop, and maintain peer-to-peer relationships with current and future Key Opinion Leaders (KOLs), Investigators, Allied Health Personnel;
- Deliver clinical presentations, product presentations, and information in response to clinicians, investigators and sites, academic settings, community and healthcare provider settings, payors;
- Report learnings and key insights from the field back into the Eiger medical team and broader organization when appropriate to support competitive awareness;
- Support Eiger clinical development activities, including site interaction when necessary, to facilitate ongoing or planned development initiatives, including patient enrollment;
- Develop and execute field regional plans in alignment with corporate strategic objectives and plans;
- Support the development, implementation, and execution of medical strategies and tactics (e.g. convention activities, advisory boards, congress symposia, regional KOL plans, and speaker programs) in close coordination with corporate objectives and plans.
Minimum Skills/Knowledge Required:
- Completed Pharm D, MD, PhD, MS in a scientific discipline preferred
- 5+ years of total pharmaceutical industry experience preferred
- 5+ years of post-professional degree practice or relevant experience (clinical practice, academic research, clinical operations, medical affairs) preferred
- Experience in literature review, analysis, and medical writing
- Hands on mentality & team-player
- Experience in Hepatology, Gastroenterology, and or rare diseases preferred
- Self-motivated, self-reliant, and able to work independently
- Knowledge of legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals
- Ability to effectively partner and maintain relationships with external stakeholders
- Ability to work cross functionally
- Excellent communication skills
- Ability to travel up to 50-60% of the time is a must
Title(s): Flexible, to be developed based on experience and fit within broader organization plan.
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
EOE
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
About Eiger BioPharmaceuticals, Inc.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Please submit your resume to:
Job Description
The Sr. Clinical Trial Manager (sCTM) / Associate Director (AD), Clinical Operations is responsible for the strategic planning, oversight and execution of Ph I/II/III studies across indications or programs. The sCTM / AD of Clinical Operations will have program oversight responsibilities while also managing study(ies). Responsibilities include, but are not limited to, establishing program study timelines and budgets, overseeing the day-to-day operations of clinical trials from study design through close-out, ensuring studies are conducted in accordance with appropriate regulatory requirements and within established timelines and budget, leading cross-functional teams and managing relationships with investigator sites, vendors and consultants. The sCTM / AD of Clinical Operations is also responsible for leading or contributing to company process improvement initiatives.
Responsibilities include, but not limited to:
- Ensure clinical studies are conducted in compliance with FDA regulations & ICH guidelines.
- Accountable for the operational delivery of responsible studies within one program or across programs, overseeing cross-functional alignment, budget, and timelines.
- Participate in program strategy meetings, contributing the operational strategy of responsible program/studies.
- Leads efforts for the selection and oversight of external service providers, including CROs and other vendors as necessary.
- Develops and manages clinical trial budgets, providing ongoing financial reporting and forecasting; oversees budgets and timelines for responsible program.
- Leads/participates in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary.
- Participate in request and review of scope of work, budgets, vendor performance and issue resolution.
- Independently manages responsible study(ies) within agreed timelines and budget and in accordance with internal SOPs and GCP, and coordinates cross-functional efforts to achieve study objectives and goals.
- Identifies and communicates study issues that will impact budget, resources and timelines. Provides support/escalation point for study team leads, as needed.
- Establishes and maintains relationships with assigned investigator sites, vendors and consultants.
- Prepares potential investigator site lists and assists with their evaluation for inclusion in the study, ensuring proper prequalification of clinical sites.
- Participates in the preparation, review and finalization of clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications as required.
- Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs.
- Participates in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program.
- Ensures Trial Master File is accurate and up to date.
- Mentors junior team members.
- Leads and/or contributes to department initiatives, and assists in the design and implementation of standardized work processes.
Minimum Skills/Knowledge Required:
- Bachelor's degree in a scientific discipline and a minimum of 10 of years of experience in clinical research working in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment.
- Experience working in Phase I, II and III in a variety of different study types, vendors and geographies
- Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
- Expertise in Microsoft Word, PowerPoint, and Excel is required and experience with Microsoft Project.
- Working knowledge of Good Clinical Practice (GCP).
TRAVEL REQUIRED
- Available for minimal travel (<30%) including overnight stays, when required.
- Ability to drive and have a valid driver’s license.
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
EOE
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
About Eiger BioPharmaceuticals, Inc.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Please submit your resume to:
Responsibilities include, but not limited to:
- The position will be responsible for all Eiger Quality Assurance GCP activities, primary responsibilities are to ensure quality and compliance of clinical trials with respect to Standard Operating Procedures and applicable regulatory requirements (FDA, EU, ICH & country-specific)
- Member of Eiger’s Quality Department reporting to the Vice President of Quality Assurance
- Assess GCP compliance risk areas, develop and implement risk mitigation measures
- Develop an audit strategy for all programs, plan and lead GCP compliance audits, including clinical investigator sites, contract clinical laboratories and contract research organizations
- Develop and implement standards, policies and clinical SOPs for GCP regulatory compliance
- Assist in the development of Clinical Quality Agreements with CROs
- Interface with relevant stakeholders, including Regulatory, Clinical, CMC, and GMP QA, as appropriate, regarding compliance issues
- Report, manage and escalate clinical deviations, investigations, corrective and preventive actions and ensure timely resolution of clinical quality issues
- Participate in the Clinical Vendor selection and management process
- Implement internal and external GCP compliance audit and inspection readiness strategy, manage regulatory inspections and the coordination of responses to resolve inspection findings
- Develop and lead GCP training of relevant Eiger functional areas
- Collaborate with Quality Systems, Quality Assurance and Quality Control functions within Eiger’s Quality Department to promote and support a unified GxP compliance strategy
Minimum Skills/Knowledge Required:
- Bachelor’s Degree in a scientific discipline and/or a combination of relevant education and applicable job experience
- 10 years in the Pharmaceutical Industry with minimum 5 years in GCP QA; experience in working across Phase 2/3 studies and BLA/NDA experience
- Solid understanding of GCP, EU, FDA and ICH regulations
- Demonstrated Issue Management and CAPA experience in a clinical environment
- Experience in planning and conducting GCP audits
- Experience with r regulatory inspections of investigator sites, sponsors or CROs.
- Experience in driving storyboard development for clinical programs
- Experience managing and resolving clinical non-compliance issues
- Experience with Quality Management Systems
- First-hand experience with GMP QA strongly preferred
- Strong critical thinking and decision-making skills
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
EOE
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
About Eiger BioPharmaceuticals, Inc.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Please submit your resume to: