Associate Director, Clinical Data Management
Company: Larimar Therapeutics
Location: Bala Cynwyd
Posted on: May 8, 2024
Job Description:
Description: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 you!We 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 Degree
- At 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
environment
- Strong familiarity Medidata RAVE, Veeva EDC or Medrio
- Strong understanding of standard GCP practices for clinical
trials
- Expertise in visualization tools/ data lakes (i.e., Spotfire,
Tableau, JMP, ellumninate, etc.) or equivalent in a clinical
database setting
- Collaborative and able to motivate and energize cross
functional team members to achieve aggressive goals
- Expertise/deep understanding of vendor management, from
selection through ongoing relationship management
- Proven ability to build relationships and manage expectations
with CROs/external vendors
- Strong problem-solving, and analytical skills, able to
facilitate discussions among groups with diverse technical
expertise, and progress decisions on complex issues
- Strong working knowledge of FDA & ICH/GCP regulations and
guidelines
- Strong 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.
PIf53abc3cfb6a-7381
Keywords: Larimar Therapeutics, Philadelphia , Associate Director, Clinical Data Management, Executive , Bala Cynwyd, Pennsylvania
Didn't find what you're looking for? Search again!
Loading more jobs...