Careers at Outcome


At Outcome, we consider our employees a key asset and a competitive advantage. We are always interested in qualified professionals in all areas of our rapidly growing company, including scientific affairs, program and research design, web development, data management, project management, user recruitment, training, support, and analytic services. We are an equal opportunity employer and offer competitive salaries and benefits. Outcome is one of the fastest growing companies in the healthcare technology and services industry. If you are interested in being part of a dynamic, emerging company, let us know.

Positions currently available: 

Corporate

Director of Human Resources

We are looking to immediately fill the Director of Human Resources position. This is a corporate role servicing the US and Switzerland. This position has ultimate responsibility for all functions of Human Resources including: staffing, employee relations, benefits, performance management, compensation management, learning and development and compliance. Candidates must have a bachelor’s degree, MBA in Organizational Behavior desired; 10-15 years in Human Resources; Knowledge of state and federal employment laws and regulations; Ability to work in a fast paced environment and effectively manage and deliver results on multiple projects simultaneously; Collaborative approach to problem solving and the ability to work effectively with individuals at all levels (internally and externally).

Professional Services

Director of Clinical Operations

We are looking for a Director of Clinical Operations. This position will have ultimate responsibility for the oversight of the Project Management and Clinical Site Management teams. This includes: Management of resources, execution of work and overall profitability of Sponsor projects; Serve as expert internal and external resource for all projects across a variety of disease areas; Define, document, implement and update methodology for launching and operating Outcome programs. Candidates must have Degree in science, public health - an advanced degree in related field or an MBA is a plus; Minimum of 12 years in applied clinical research, with some experience with observational safety studies and at least 5 of those years at the management level; Must have excellent communication and interpersonal skills, be highly organized and self motivated with a proven ability to determine and meet objectives; the ability to collaborate with other managers to ensure appropriate direction and supervision of shared resources is critical.

Project Manager/Senior Project Manager (2) - Association

With direct supervision from the Program Manager or a Senior Project Manager, the Project Manager is responsible for all aspects of project administration and data coordination for multiple large-scale, Internet-based outcome studies.  Based on experience and advances project management skills, PM's will be placed on projects that are of significant revenue importance and/or have a high degree of complexity (i.e., breadth and/or depth of scope in client requirements).  This positon requires a Bachelor's degree (Master's degree preferred) and 2 or more years of Clinical Project Management experience in the healthcare, medical research, or healthcare technology setting.  Candidates must have excellent communication and organizational skills and have proven ability to manage large-scale projects. 

Clinical Data Manager

As a member of the Data Management team you will be managing database development and data review for clinical trials and patient registry programs in compliance with standard operating procedures, client guidelines, contractual obligations and regulatory agency guidelines. Among other responsibilities you will review clinical trial and patient registry data according to client needs, protocol endpoints from a risk management approach and develop CRFs and eCRFs for completeness, content, standards, and database considerations. This position requires a Bachelor’s degree; two or more years of experience working within the healthcare/technology industry and experience working with EDC and databases. The ideal person will also have the ability to learn quickly, multi-task and prioritize; superior computer, organizational, communication (both written and verbal) and client service skills.

Technical Project Manager

The Technical Project Manager will define technical requirements, create/approve project specifications, manage project team resources in all departments and communicate directly with clients to facilitate successful project delivery. This person will improve the quality and coverage of technical documentation and work with management to identify and prioritize documentation needs. This individual may manage and mentor a team. The requirements for this role are; Bachelors degree, Engineering or Computer Science preferred, 4+ years of software or technical writing experience and must have superior written and verbal communication skills. The ideal candidate must have successful client facing experience, be a self-starter and have the ability to take initiative and be decisive.

Technical Support Representative

The Technical Suuport Representative will support physicians, nurses, pharmacists, and other healthcare workers in the use of the company's internet-based data management tools and in all aspects of Site Management including site recruitment, site qualification, site enrollment (including IRB/EC support and regulatory document collection), training, ongoing support, and monitoring of customer satisfaction.  The requirements for this role include: Bachelor's degree; excellent phone skills; ability to learn quickly, prioritize, and multi-task; and must be detail-oriented, professional, and have strong communications skills.

Engineering

Product Manager

The Product Manager develops and manages the technical product plan for specific product offering(s) including defining the market opportunity; conducting competitive analysis; market/customer requirements; conducting competitive analysis; value proposition and messaging; product vision, definition and roadmap. The Product Manager will work collaboratively with a cross-functional team to successfully execute the business/product plan and deliver on client product-specific requirements and project success. This position requires a Bachelors Degree with a Masters Degree preferred, 2+ years of technical project management with programming experiencing a plus. Prior experience in software product management, exposure to systems that support clinical research or healthcare is preferred. It is required that the candidate must also have the ability to lead a cross-functional team to drive product development, implementation and launch.

Quality

Clinical Quality Assurance Manager

This position is responsible for developing and maintaining the quality management system documentation, including documents specific to regulatory and compliance processes and procedures; overseeing internal training, including regulatory and compliance training; serve as in-house consultant for understandig project-specific requirements regarding national, regional, and local laws and regulations (e.g., privacy, data protection, ethics) and ensuring compliance; and perform audits of internal processes and procedures, perform quality audits of external vendors and partners to evaluate prospective groups and review ongoing work under contract, and perform audits of project procedures, training, documentation, and records.  The right candidate will have 4 or more years experience in the Quality field within the Life Sciences industry; experience performing process and documentation audits; experience developing process documentation; ability to understand and interpret national, regional, and local regulations related to Outcome's work.

Scientific Affairs

Director of Biostatistics

The Director will lead statistical work and analysis for client projects worldwide, including participating in proposals, preparing and executing statistical analysis plans, evaluations of analyses and team deliverables as well as client consultation and presentations. This role is a key part of our scientific consulting team, and will have strong interface and collaboration with our epidemiologists, clinical project managers, business development directors, data managers, statistical programmers, etc. This person will help develop a technical team of programmers and analysts. The Director will recommend and conduct biostatistical activities in support of the design and completion of observational studies of comparative effectiveness and safety, as well as other observational pharmacoepidemiologic and outcomes research; apply knowledge and experience to complex and/or novel research questions in a way that adds value, design and conduct descriptive and inferential statistical analyses; write statistical portion of some study protocols and statistical analysis plans, develop sample size/power calculations, stratification, and, on occasion, randomization schema, consult on data collection methods and quality control to ensure availability and validity of required output for analysis. It is preferred that the ideal candidate have a doctorate in biostatistics, with a strong design and analytic track record and at least 10 years experience, experience working for or with pharmaceutical, biotech, medical device companies, or CRO; strong working knowledge of relevant statistical methodology (e.g., GLM, logistic regression, non-parametric and exact procedures , Bayesian analysis, and study size calculations); with knowledge of SAS a plus. The candidate must have strong oral and written communication skills, including the ability to convey biostatistical principles to colleagues with varying functional specialties and backgrounds, have extensive experience writing statistical analysis plans and summarizing the results of studies for the pharmaceutical or CRO industry. This person must also be technically proficient, as hands-on work, review and interface in technical client discussions is required.

Biostatistician                                                                                                     

As a Biostatistician you will work within scientific affairs, and closely with data management, regulatory & other functional groups to provide strategic input into observational research on the natural history of disease and comparative safety and effectiveness, to propose methodologically and statistically sound study design and data analysis plans to meet project objectives and regulatory requirements, and to conduct and supervise performance of analyses, evaluation and reporting. In this role, you will recommend and conduct biostatistical activities in support of the design and completion of observational studies, design and conduct descriptive and inferential statistical analysis, develop sample size/power calculations, and stratification or randomization schema along with consult on data collections methods and quality control to ensure availability and validity of required output for analysis. The ideal candidate will have a doctorate in biostatistics with a strong analytic track record and at least 5 years of biopharmaceutical experience. Candidates with an MS degree in biostatistics or statistics degrees and significant statistical and analytic experience may also be considered. Experience with general linear models, logistic regression, non-parametric and exact procedures, Bayesian analysis, and study size calculations along with having the ability to convey biostatistical principles is required. Also needed is a demonstrated ability to recommend plans for research design, strong working knowledge of relevant statistical methodology, experience in SAS and having the ability to work on multiple projects.

Director of Epidemiology

As a Director of Epidemiology you will work within scientific affairs, and closely with data management, regulatory & other functional groups to provide strategic input into biopharmaceutical post-marketing project development, to propose methodologically and statistically sound study design and data analysis plans to meet project objectives and regulatory requirements, and to conduct and supervise performance of analyses, evaluation and reporting. The ideal candidate will have a doctorate in epidemiology with a strong analytic track record and at least 5-10 years of biopharmaceutical experience, however candidates with lesser degrees and significant statistical and analytical experience may also be considered. This person must have strong oral and written communication skills and demonstrated ability to recommend plans for research design.

Research Associate

In this role, you will review current disease and outbreak information from multiple data sources, coordinate the accurate and prompt flow of information to the project team, track project initiatives, assist in outreach activities and assist in data collection and management. This position requires a mature and flexible candidate who possesses cultural sensitivity and knowledge of the international public health community. Candidates must have a Bachelors degree, but having a Masters Degree or coursework towards a degree in Epidemiology or Public Health a plus. Candidates must also have 2 to 4 years experience in public health, life sciences or a related research field, have excellent research and analytical skills including the ability to understand and synthesize medical and public health scientific information, excellent writing and communication skills along with the ability to work effectively in internal and external project teams. Demonstrated multi-tasking, organizational skills with the ability to meet competing deadlines are necessary. Some travel may be required.

Outcome Europe

Professional Services

Senior Clinical Project Manager / Clinical Project Manager

As Project Manager you will be responsible for providing overall project management of multi-national Phase IV/Post-Market Surveillance Programs and Registries, including interventional and non-interventional studies, post-authorisation safety studies (PASS), and drug & disease registries. Representing the company and working within an international environment you will work with pharmaceutical, biotechnology and medical device industry to execute assigned studies and ensure agreed scope delivery. As Senior Clinical Project Manager will also have line management responsibilities.

The successful candidate will have: A Medical or Life Sciences degree with Project Management experience, or at least 2 years in a Lead CRA position with a desire to advance in your career. The Senior Project Manager candidate should have at least 5 years of Project Management experience. Phase IV experience and EDC expertise is highly recommended. Proven ability to independently manage large-scale projects - with excellent communication and strong leadership skills. Fluency in English is required. Other languages would be an asset.

Lead Clinical Research Associate                                                                           

As Lead CRA you will be responsible for overseeing all monitoring activities on a project level for multi-national Phase IV/Post-Market Surveillance Programs and Registries including interventional and non-interventional studies, post-authorisation safety studies (PASS), and drug & disease registries. You will be the point of contact for all CRAs and will be responsible for ensuring that CRAs are trained on study requirements. As Lead CRA you will also oversee study start-up activities, including site selection and regulatory document collection, development of monitoring plans and study templates and during study operations you will be responsible for reviewing monitoring visit reports and ensuring CRA adherence to study timelines and budget. You will also present at and participate in Investigator Meetings, other study trainings and meetings as required and act as a mentor for more junior Clinical Research Associates.

Working within an international environment you will work with pharmaceutical, biotechnology and medical device industry to execute assigned studies.

The successful candidate will have: A Bachelor’s degree in Life Sciences or equivalent nursing qualification with a minimum of 2 years multi-national experience as a CRA. Phase IV clinical trial experience and EDC expertise is recommended. Qualified candidates will possess excellent communication skills; excellent organizational skills, proven decision making and problem solving abilities; and demonstrated ability to manage multiple priorities. Fluency in English is required. Other languages would be an asset.

Corporate

Global Regulatory Manager

As the Global Regulatory Affairs Manager, you will maintain awareness of current regulatory requirements, trends and developments related to post-approval/Phase IV clinical research and inform project teams, clients and senior management of changes. You will ensure that the company's internal and external activities comply with global regulatory requirements for both pharmaceutical (80%) and medical device (20%) products through collaboration with other departments, training and review of internal processes and procedures (SOPs). The ideal candidate will have 5+ years of direct regulatory experience, preferably with at least 2 years working for a global CRO, including work on global Phase IV/post-approval studies as well as Extensive knowledge of applicable regulations, including EU Clinical Trials and Data Protection Directives, Declaration of Helsinki (1996), ICH, GCP, EFPIA Code of Practice, HIPAA, applicable country-specific regulations, etc. Broad global regulatory experience is required, especially in Europe. Must be interested and knowledgeable in obtaining regulatory guidance on clinical operations in other regions of the world. Bachelor’s (or Master’s) degree in a scientific, medical or relevant discipline is preferred. Fluency in at least French and English, with strong English speaking and writing skills is required. Swiss nationality, Swiss C, B, G working permit, OR EC European nationality.


Scientific Affairs

Director of Epidemiology

As a Director of Epidemiology you will work within scientific affairs, and closely with data management, regulatory & other functional groups to provide strategic input into biopharmaceutical post-marketing project development, to propose methodologically and statistically sound study design and data analysis plans to meet project objectives and regulatory requirements, and to conduct and supervise performance of analyses, evaluation and reporting. The ideal candidate will have a doctorate in epidemiology with a strong analytic track record and at least 5-10 years of biopharmaceutical experience, however candidates with lesser degrees and significant statistical and analytical experience may also be considered. This person must have strong oral and written communication skills and demonstrated ability to recommend plans for research design.


         

Please send resume and cover letter to:

Careers USA                                                         Careers Europe
Outcome Sciences, Inc.                                           Outcome Europe Sarl
201 Broadway, 5th Floor                                          Chemin du Glapin 6
Cambridge, MA 02139                                             1162 St. Prex, Switzerland

             Or                                                                            Or

Email: careers@outcome.com                               Email: careereurope@outcome.com

Email is preferred.

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