Clinical Project Manager

Altus® is focused on developing and commercializing novel protein therapeutics for patients with chronic gastrointestinal and metabolic diseases. Altus' in-depth knowledge of protein crystallization has resulted in a proprietary pipeline of orally-delivered and injectable protein replacement products. As a company, we are committed to improving the quality of life of patients.

Our success is a result of our ability to recruit and retain highly qualified and motivated people who are among the best in the industry. Located in the heart of the biotechnology industry, Altus is only steps from two of the world's premier scientific research institutions and within miles of some of the country's leading hospitals and physicians. We seek to leverage this location to attract some of the best and brightest individuals in the field and foster innovation in a fun and exciting entrepreneurial setting.

This position is responsible for providing appropriate support for at least one clinical trial. The selected individual will coordinate clinical project team members to appropriate and timely completion of projects, and supports management of project timeline. Internally, this individual will interface with the Clinical Program Manager, the Director of Clinical Operations, Medical Director’s, Data Management and Biostatistics, Regulatory Affairs and QA. This individual will participate in the management of external vendors, field monitors, and investigator site staff. This individual is responsible to make certain the trial is managed to the highest quality. This individual will work under the direction of management on challenges where analysis of situations or data requires an in-depth evaluation of various factors. This position reports to the Clinical Program Manager.

This position offers great opportunity to the ideal candidate who has experience with MS Project, a familiarly with clinical trials, eager to take on new challenges and able to handle ambiguity.

Duties and Responsibilities:
Responsible and accountable for one or more concurrent clinical studies
Leverages resources, expertise and knowledge across projects
Prepares and manages trial budget
Trains and mentors junior staff
Negotiates contracts and budgets with clinical sites and vendors for approval by senior management
Participates in protocol development
Develops critical study documents including informed consent forms, study conduct documents such as study manuals, study tools etc
Prepares investigational site lists, participates in reviewing and approving investigational sites based on complete site assessment
Drafts, reviews and submits for approval instructions for use of study drug
Manages the coordination of and attends investigator and coordinator meetings
Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
Participates in the dissemination of clinical information to the clinical team members
Reviews and approves corrective action plans at individual site and across study, may participate in internal/external study related audits
Must be able to monitor as needed

Competency Expectations:
Good verbal and written communication skills
Excellent interpersonal and organizational skills
Detail oriented and good problem solving ability
Ability to work on teams and with multiple projects, and works well under general direction
Working knowledge of medical terminology
Excellent computer skills
Excellent knowledge of GCP, ICH and FDA regulations
Ability to provide significant tactical guidance to Clinical staff
Independently motivated

Altus Pharmaceuticals is an equal opportunity employer.

Note To Recruitment Agencies:

Altus Pharmaceuticals does not accept unsolicited resumes from any agencies or individuals that offer candidates for a fee. Any recruiter or agency seeking to work with Altus Pharmaceuticals must contact human resources at careers@altus.com and enter into a signed fee agreement. Resumes submitted to Altus hiring managers or employees without consent will be deemed the property of Altus Pharmaceuticals Inc.
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