cdi clinical data management study lead rare disease h/f
Detail de l'annonce :
The Clinical Data Management (CDM) Study Lead defines, implements and
monitors the Data Management strategy for one or more clinical studies
in Ipsen portfolio. He/She is responsible for delivering of
high-quality databases by external vendors in adherence to Ipsen
standards, meeting project timelines and budget. This includes
monitoring the quality, anticipating and mitigating the risks as part
of the risk management plan and measuring the performance through
metrics and KPI.
He/She represents the CDM function in the clinical study team(s),
discuss and explain the DM needs and constraints within these Teams
and inform the CDM program Lead on advances and issues for the
projects.
He/She is the Data Management subject matter expert (SME) and
consequently is accountable for the Data Management deliverables of
his/her projects. He/She ensures that the clinical data collected,
processed and reported are supported according to high quality,
rigorous, objective and informative Data Management procedures and
processes.
He/She ensures that clinical databases in the project(s) are
consistent with Ipsen data standards and presented to the analysis and
reporting process in such a way the evaluation of data will withstand
interrogation and examination by regulatory bodies.
He/She participates to the Service Provider selection (from Scope Of
Work to contract including Bid defence) oversees external vendors for
outsourced activities and is responsible for the corresponding
deliverables (quality, budget and timelines). He/She follows metrics
and KPIs, implements corrective actions and escalate to the DM Program
Lead when necessary.
He/She acts as the reference in terms of Data Management specifics
related to the rare diseases.
MAIN RESPONSIBILITIES / JOB EXPECTATIONS
Related to study activities:
* Organize and coordinate the Data Management activities from
clinical synopsis / protocol review to the clinical study report and
up to clinical data submission when applicable, in accordance to
program level specificities
* Define and put in place a high quality, timely and robust data
management strategy for the project (e.g. data capture tool,
management of external data, data flow for submissions). Develop and
implement project specific guidelines and support documentation
* Ensure that the Data Management activities related to collection,
processing and data transfers to the Ipsen data warehouse are
conducted in compliance with procedures and best practices
* Participate to selection of external vendors by evaluating their
ability to deliver in the context of Ipsen projects.
* Oversee the external vendor’s activities and deliverables and
report on the status of Data Management tasks as needed to the Study
Team / Submission Team. Make sure that subcontracted activities are
delivered in line with the project expectations (timelines, quality
and budget). Follows budget and potential change orders in relation
with the Clinical Development Programs Department.
* Ensure compliance of the data management deliverables with Ipsen
rules and standards (e.g. standard database within Ipsen data
warehouse) and ensure that the requirements from the clinical study
protocol and the statistical analysis are fulfilled.
* Monitor the data quality, completeness and trend between subgroups
(e.g. between countries, centres…) at different pre-identified and
agreed time point in a project corresponding to milestone such as data
review, DMC, interim analysis using tools such as those developed for
risk based monitoring. He/She follows metrics and KPIs, implements
corrective actions in conjonction with Study Team / Project Team and
escalate to the DM Program Lead when necessary.
* Coordinate all necessary activities to reach in a timely manner
the database lock milestone such as making sure that the last transfer
is complete (included all external data, randomization data, coding,
SAE reconciliation is complete).
Processes and recommendations
* As an expert of the rare disease field, support the standard team
in setting up therapeutic area specific standards, advice study teams
in terms of best practices on data collection and usages, supervise
CROs if needed.
* Participate to the implementation of data quality systems and
procedures and identify any needs for improvement.
* Perform new technologies intelligence and adapt to them as
appropriate. Participate in the continuous improvement of the Data
Management system in Ipsen.
Specifics of Position
Ability to manage data management projects: plan activities and
tasks, identify project constraints and dependencies, identify and
mitigate risks, report on project status, produce progress metrics,
and communicate efficiently with external vendors as well as internal
partners
Ability to produce high quality, accurate work to meet deadlines
Ability to satisfactorily interact with staff from differing
disciplines
Responsible, flexible and accountable with a pro-active approach
Ability to perform technical tasks and good understanding of
clinical database structures and models
Understand the basic needs of statistics and programming
Understand the basics of the disease area
EHS Mission / Duties to be performed on the site of Les Ulis
Within its sphere of activity, to respect the regulation, to apply
the IPSEN good practices and standards, and the EHS procedures set up
on the site.
Participate at the EHS training, proposed in the framework of the
training at post of work.
Contribute to reduce the environmental impact of the activities on
the site.
Inform his / her superiors of any changes affecting the post of
work, so that the single document evaluation of occupational risks,
can be updated, as well as any useful information to better take into
account the EHS on site
KNOWLEDGE, ABILITIES & EXPERIENCE
EXPERIENCE:
* Ideal: More than 5 years of experience in Clinical Data Management
* Minimum: 4 years as Clinical Data Manager with proven project
management capabilities in a pharmaceutical company or in a CRO and at
least one project on a neurological disease
* Experience of working with multidisciplinary groups and ability to
work within a team environment.
* A good understanding of the drug development process
* Good budget management understanding
* Excellent organizational and project management skills
* Good verbal and written communication skills.
Qualification :
* Ideal: advanced degree in life sciences and/or Information
Technology applied to life sciences
* Minimum: a minimum of a graduate degree
* Language: fluent in English; French would be an advantage
Key Technical Competencies Required
* Advanced knowledge of clinical studies’ Data Management
* High knowledge of international standards (ICH, GCP, CDISC …)
and regulations related to clinical studies, electronic data capture
and data management
* High level of expertise in the use of the data-management software
including for example Medidata RAVE
* knowledge of SAS programming
* Good level of expertise of oversight and management of external
vendors
* diagnostic, analytical and process improvement skills
* Excellent IT and Microsoft Office skills
* Strong attention to detail, excellent and direct communication
skills, strong interpersonal skills, and cross-cultural understanding
and sensitivity
* Ability to represent the company in a highly professional manner.
* Ability to take initiative with a positive attitude in all
circumstances.
* Flexible; independent problem solving and self-direction.
* Eager and interested in learning and growing
Other Useful Information
* Key Internal stakeholders: Clinical Operations, Pharmacovigilance,
Biostatistics, Medical Writing, Therapeutic Areas, REED, R&D
Operations, GRA, Finance
* Key External contacts: External vendors, central labs and readers,
Professional Associations
* Financial budget: Between 300K€ and 2M€ per study
* Number of direct reports: none.
The statements contained herein reflect general details as necessary
to describe the principles functions for this job, the level of
knowledge and skill typically required, and the scope of
responsibility, but should not be considered an all-inclusive listing
of work requirements. Individuals may perform other duties as
assigned, including work in other functional areas to cover absences
or relief, to equalize peak work periods or otherwise balance
workload.
This description is not intended to be constructed as an exhaustive
list of duties, responsibilities, or requirements for the position.
This position may change or assume additional duties at any time. The
employee may be requested to perform different or additional duties as
assigned. All Employees are expected to adhere to all company policies
and act as a role model for company values.
Localisation les Ulis
Dans le cadre de ses recrutements IPSEN s’engage au respect de
l’égalité de traitement des candidats, indépendamment du sexe, de
l’âge, de l'orientation sexuelle, de l'origine ethnique, de la
couleur de la peau, de la nationalité, du handicap ou de
l'appartenance à un syndicat.