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Senior Data Manager
Il y a 3 mois
Clinical Data Manager (CDM)
About Corteria Pharmaceuticals
Corteria Pharmaceuticals is a privately held company that develops first-in-class drugs in subpopulations of heart failure and obesity. Our programs aim to treat well defined heart failure subpopulations (worsening heart failure, acute heart failure with hyponatremia, right heart failure) and obesity with co-morbidities.
We develop several drug candidates on clinically validated targets: CRF2 and vasopressin
- CRF2 projects: endogenous CRF2 ligands (urocortin 2 or stresscopin) have been validated in heart failure patients but their very short half-life which makes them unsuitable for subchronic use. Our strategy is to develop a potent, selective, long-acting CRF2 agonists suitable for subcutaneous administration for the treatment of worsening heart failure and obesity.
- Vasopressin project: therapeutic targeting of vasopressin requires the blockade of its 3 receptors (V1a, V1b, V2) which cannot be achieved today by a small molecule approach. To overcome this issue we are developing a neutralizing human monoclonal antibody directed against vasopressin to provide a therapeutic solution to hyponatremic acute heart failure or ADPKD patients.
To support the clinical development of our projects, we are looking for a Clinical Data Manager (CDM) who will supervise all the data management (DM) activities performed by the Clinical Research Organizations (CROs) in charge of our clinical trials and will collaborate with study team to ensure the timely and accurate collection, processing, and reporting of clinical trial data.
Position Summary:
The CDM is a well-organized and detail-oriented individual with strong knowledge of clinical data management processes and standards, who has excellent problem-solving, analytical and teamwork skills and is able to multi-task on competing projects ensuring the accuracy, integrity, and security of data collected during clinical trials.
Major Duties and Responsibilities:
· Supervise the DM activities carried out by the CROs from the establishment of the electronic Case Report Forms (eCRFs) to the freezing of the databases
· Validate the deliverables of the CROs (eg Data Management Plan, eCRF/Database structure, Data Validation Plan, external data transfer specifications, data reconciliation, Study Data Tabulation Model (SDTM) specifications / database in SDTM format, coding plan, Deviation Assessment Plan)
· Prepare and review the data transfer agreements
· Ensure the compliance to General data Protection Regulation (GDPR)
· Act as the primary point of contact for data management-related activities with CROs.
· Test electronic data capture (EDC) systems for data collection
· Review reports/checks/queries used by the team to ensure data quality
· Collaborate with study team members to resolve data-related issues and discrepancies
· Oversee data cleaning activities, including query resolution
· Present the progress of DM activities to the project team
· Serve as the escalation point for unresolved data issues
· Check the quality of the database for statistical analysis before the database is frozen
· Support database lock activities
· Archive documentation related to DM activities
· Provide suggestions on how to improve DM operating procedures
· Ensure data management practices comply with Good Clinical Practice (GCP), FDA regulations, and other relevant guidelines.
· Participate in the selection of CROs by reviewing proposals and budget forecasts regarding the DM activities
Requirements/ Qualifications:
Education:
· Bachelor’s degree in computer science, data science, or related scientific/healthcare discipline is required
Experience:
· A minimum of 5-year experience in clinical data management in the pharmaceutical industry or CRO is required. Experience working in a biotech company is preferred
· Solid knowledge of the Clinical Data Interchange Standards Consortium (CDISC) standard (SDTM)
· Proficiency in using clinical data management systems (e.g., Oracle Clinical, Medidata Rave, SAS, etc.)
· Familiarity with regulatory requirements (e.g. ICH/GCP), industry standards and Privacy Impact Assessment
· Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology.
Language:
- Proficient written and oral communication skills in English is key for this position.
Work setting:
- Hybrid with 1 or 2 days per week at the office in Massy, France is preferred
