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Associate Director, Clinical Data Management
4 months ago
The Company: We are Larimar Therapeutics, based in the Philadelphia area, and committed to discovering and developing therapeutics to dramatically improve the lives of patients with complex rare diseases. At Larimar, we embrace everyone's contribution to our Mission. Our values connect us and ensure we communicate openly, treat each other with respect, help us grow from our successes and failures, and innovate. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome youWe are a clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, CTI-1601, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and about 40 employees. Our management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs and the development of manufacturing processes utilizing good manufacturing practices (GMPs).Our strategy is to become a leader in the treatment of rare diseases by leveraging our technology platform and applying the team's know how and expertise to the development of CTI-1601 and other future pipeline programs.Position Summary: The Associate Director of Clinical Data Management will provide support for Clinical Studies and provide oversight of DM CROs. The Associate Director, Clinical Data Management will be instrumental in supporting the management of outsourced studies, by ensuring that contracted activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the execution of a clinical trial to support drug development processes and global submissions through to approval, as well supporting standards, infrastructure and technology initiatives and strategic vendor relationships.Job Responsibilities: The responsibilities may include but are not limited to the following activities:Provide independent project-level oversight of clinical data management activities, monitors, and reports on overall study progress.Ability to perform Clinical Data Management responsibilities on all assigned studies.Ability to collect requirements for data visualization tools to support development of DM operational standards and test requirements.Ensure oversight of the Data Management vendors at the portfolio level; developing managing & reviewing metrics, to identify and mitigate database and or operational issues toward resolution.Manage and facilitate relationship and escalation meetings as needed to maintain expected performance and/or mitigate poor vendor performance and propose resolutions for poor performance.Ability to develop, draft and finalize Data Management systems, templates, processes and responsibilities across department toward overall operational standardization.Monitor quality of data deliverables from external vendor sources used for the clinical database for all assigned studies with focus on assessing and producing metrics on overall database trends, including but not limited to EDC, eTMF, etc.Ability to development/oversee Data Management specific documentation independently including but not limited to the eCRF specifications, eCRF completion guidelines, edit check specifications, validation documents, DMP and DRP (Data Review Plan)Oversee the activities of applicable Data Management study vendors and CRO Data Management functional counterparts to ensure adherence to scope of work and service agreements, to ensure deliverables are met in accordance with study milestones/timelines and with expected data quality and budget.Oversight of contracts, budgets and accruals, assurance these are maintained in a timely fashion as to not impact and delay study timelines.Oversee and perform required User Acceptance Testing and development testing of the eCRF and associated database technology prior to deployment, inclusive of creating/following User Acceptance Test (UAT) Plans and Test Scripts and executing testing as applicable.Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel.Oversee the performance and quality issues with vendors, and escalates to management and develops appropriate risk mitigation and/or escalation to Quality Assurance independently.Support study-level audit and inspection readiness activities.Coordinate development and maintenance of SOPs, processes, and guidelines. Requirements Bachelor's DegreeAt least 10-15 years of experience as a Senior or Lead Clinical Data Manager leading clinical data management activities for multiple studies or a clinical program(s) including oversight of multiple CROs and vendorsExcellent interpersonal, communication, and organizational skills with the ability to manage multiple programs and processes simultaneously in a fast paced, team-based environmentStrong familiarity Medidata RAVE, Veeva EDC or MedrioStrong understanding of standard GCP practices for clinical trialsExpertise in visualization tools/ data lakes (i.e., Spotfire, Tableau, JMP, ellumninate, etc.) or equivalent in a clinical database settingCollaborative and able to motivate and energize cross functional team members to achieve aggressive goalsExpertise/deep understanding of vendor management, from selection through ongoing relationship managementProven ability to build relationships and manage expectations with CROs/external vendorsStrong problem-solving, and analytical skills, able to facilitate discussions among groups with diverse technical expertise, and progress decisions on complex issuesStrong working knowledge of FDA & ICH/GCP regulations and guidelinesStrong knowledge with CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11, Good Clinical Data Management Practices (GCDMP)Experience with eTMFs pertaining to CDM documentation. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.
