Clinical Data Management Study Lead

Title:Clinical Data Management Study Lead

Company:Ipsen Bioscience, Inc.

Job Description:

Clinical Data Management Study Lead

Summary/Purpose of the Position:

The Clinical Data Management (CDM) Study Lead defines, implements, and monitors the Data Management strategy for one or more clinical studies in Ipsen portfolio. The Study Lead is responsible for delivering high-quality databases by external vendors in adherence to Ipsen standards, meeting project timelines and budgets. 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.

The CDM Study Lead represents the CDM function in the clinical study team(s); discuss and explain the DM needs and constraints within these teams and informs the CDM program Lead on advances and issues for the projects.

The CDM Study Lead is the Data Management subject matter expert (SME) and consequently is accountable for the Data Management deliverables of assigned projects. The Study Lead ensures that the clinical data collected, processed, and reported are supported according to high quality, rigorous, objective, and informative Data Management procedures and processes.

The CDM Study Lead 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.

The CDM Study Lead participates in the Service Provider selection (from Scope of Work to contract, including Bid defense), oversees external vendors for outsourced activities and is responsible for the corresponding deliverables (quality, budget, and timelines). The Study lead will follow metrics and KPIs, implement corrective actions and escalate to the DM Program Lead when necessary.

The CDM Study Lead acts as the key contact in terms of Data Management specifics related to the relevant DM activities.

Main Responsibilities/Job Expectations:

Responsibilities include, but are not limited to the following:

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 with 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, centers…) 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. Follows metrics and KPIs, implements corrective actions in conjunction 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 & Recommendations:

As an expert of the therapeutic area 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 therapeutic area.

EHS Mission / Duties to be performed at the Cambridge Site :

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 their 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 consider the EHS on site.

Knowledge, Abilities & Experience:

Education:

Bachelor’s degree in related field required.

Advanced degree in life sciences and/or Information Technology applied to life sciences is preferred.

Experience:

5+ years’ experience in Clinical Data Management

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

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

SAS programming knowledge

A good understanding of the drug development process

Good understanding of budget management

Experience working with multidisciplinary groups and ability to work within a team environment

Languages:

Fluent in English required.

French is a plus.

Key Technical Competencies Required:

Excellent organizational and project management skills

Good verbal and written communication skills.

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.

The annual base salary range for this position is $112,599 - $165,000.

This job is eligible to participate in our short-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

R-16548