Data Manager

Offer Description

- Responsible for clinical / patient data acquisition and management;
- Managing data for complex studies within agreed timescales;
- Responsible for implementing systems to monitor timeliness of data entry;
- Manage a team of data staff to ensure data is entered and site files are managed providing a high-quality data service to Principal Investigators and study teams. Responsible for clinical / patient data acquisition and management;
- Managing data for complex studies within agreed timescales;
- Responsible for implementing systems to monitor timeliness of data entry;
- Manage a team of data staff to ensure data is entered and site files are managed providing a high-quality data service to Principal Investigators and study teams.

Duties and Responsabilities

Main duties will include

- Create and maintain Data Management documentation and guidelines;
- Review and validate the data in clinical and non-interventional studies;
- Plan and execute multiple Data Management projects simultaneously;
- Resolve any issues throughout the project lifecycle;
- Demonstrates ability to conduct most of the Data Management activities; 
- Management of deliverables for programs sent to sponsors; 
- Standardisation of data management procedures; 
- Train and support others to conduct data management processes; 
- Any other duties as directed by the Line Manager. 

Legal Requirements

Data management will be applied in accordance with EU, National, and Foundation regulatory requirements.

Research

- Work with the research team to ensure study documentation is prepared for audit and regulatory inspection;
- Monitor the data queries from study sponsors;
- Report serious adverse events;
- Monitor the timelines of data entry; 
- Provide support to the Quality Assurance Manager and Clinical Studies Manager;
- Oversee the archiving of study documentation;
- Oversee the maintenance of current protocols and patient information sheets/consent forms;
- Be responsible for the documentation of trial data;
- Assist in the development and maintenance of databases as appropriate;
- Assist in the delivery of internal audits and reviews;
- Develop trial worksheets for new studies.

Data Management

- Be responsible for the data entry;
- Ensure trial case report forms are completed; 
- Assist with resolution of queries when required.

Management

- Be responsible for training new data staff;
- Take responsibility for promoting a safe environment and safe patient care;
- Participate in trial set-up and the review of required resources to facilitate new trials.

Where to apply

E-mail: recruitment.botton@research.fchampalimaud.org

Requirements

Research Field

Biological sciences, Computer science and Biological sciences

Education Level

Master Degree or equivalent

Skills/Qualifications

- Leadership;
- Problem solving;
- Flexibility;
- Attention to detail;
- Communication;
- Organisation;
- Initiative.

Specific requirements

Essential qualifications

- University degree or equivalent in Medical Documentation/Life Science/Biological science/Informatics or a related discipline in the science/healthcare field; 
- Experience in (Clinical) Data Management within a pharmaceutical company or CRO; 
- Good understanding of ICH-GCP principles;
- IT programming skills; 
- Ability to work both independently and efficiently within an interdisciplinary team;
- Planning, organisation, and communication skills;
- Proficient computer skills in MS Office Excellent command of both written and spoken English;
- Develop positive relationships with internal teams and stakeholders.

Desirable qualifications

Proficient in both English and Portuguese

Key relationships

Internal                                                                               

- Head of Clinical Documentation Staff;
- Head of Translational Research;
- Head of Laboratory Operations;
- Health & Safety Officer;
- Research Group Leaders;
- Scientific Researchers;
- IT;
- HR;
- Finance.

External

- Company service engineers; 
- Company sales reps.           

Eligibility criteria

Candidates must provide

- A completed application form, - Call Ref." DataManager_BCPCC”
- A letter of motivation (max. 2 pages), highlighting your suitability for the role, salary expectations and notice period
- CV (max. 2 pages)
- Names and contact information for at least 2 references. If you do not wish that we contact current or past employers, please state so and why in your letter of motivation. 

Selection process

Evaluation and Selection Criteria. All CVs and motivation letters will be reviewed by the selection committee. Reference letters will be requested from shortlisted candidates, and those candidates deemed particularly well suited for the position will be invited for an interview.

More about us

The Botton-Champalimaud Pancreatic Cancer Centre is a state-of-the-art facility comprising research laboratories, a day hospital, a surgical centre, as well as inpatient and intensive care facilities.  The mission of the Botton-Champalimaud Pancreatic Cancer Centre is to develop new and effective treatments for pancreatic cancer. To accomplish this goal a multidisciplinary team of surgeons, clinicians, clinical trials specialists, cancer scientists, genomics experts and computational biologists work together to deliver world-leading outcomes for patients with pancreatic cancer.

The Botton-Champalimaud Pancreatic Cancer Centre is also closely integrated with the Champalimaud Centre for the Unknown. Members of the Champalimaud Research Programme (CR) and the Champalimaud Clinical Centre (CCC), work together to investigate fundamental biological processes and search for effective solutions to alleviate the burden of oncological, neurological and mental diseases, while providing state-of-the-art care to the patients of the CCC. With 479 members, including group leaders, postdocs, PhD and MSc students, research technicians and highly specialised research staff, the CR community encompasses 39 nationalities. Within the Lisbon Ocean Campus, CF will expand its research, technological development, innovation, and clinical practice in the digital therapeutics field.

Additional Institutional Information

In line with our community guidelines and Equality, Diversity and Inclusion policy and Gender Equality Plan, no candidate may be privileged, favoured, prejudiced or deprived of any right or excluded from any duty on the basis of age, sex, gender identity, sexual orientation, race/ethnicity, disability, chronic illness, language, nationality, territory of origin, family status (marital, pregnancy and maternity, having or not having dependents), socioeconomic situation, education, religion, political or ideological beliefs, trade union membership, or on any other grounds which are irrelevant to decision-making. 

HR Excellence in Research

Legal Notices

The present call has the sole purpose of filling the indicated research position. This call may be cancelled at any time on or before the jury’s evaluation of all eligible candidates and the recruitment process shall be concluded on the day of the full execution of the contract between the Champalimaud Foundation and the selected candidate.