Associate Director, Clinical Data Management
Company: Larimar Therapeutics
Location: Bala Cynwyd
Posted on: May 8, 2024
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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. PI850e8a3c7ecf-35216-34347381
Keywords: Larimar Therapeutics, Wilmington , Associate Director, Clinical Data Management, Executive , Bala Cynwyd, Delaware
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