Clinical Research Manager

Organisation Description
EMD Serono, Inc. is a leader in US biotechnology, focusing on reproductive health, metabolic endocrinology, and neurology. More than 500 people work in the world-class facilities in Rockland, MA, and approximately 250 work in the field.
Description

PURPOSE OF THE ROLE:Providing line management and leadership to a group of Clinical Trial Managers (CTMs) or Clinical Trial Coordinators/Administrators (CTCs/CTAs). Oversee all aspects of performance relating to Clinical Trial Management assigned to his/her group on agreed quality, time and budget. Ensuring the successful and standardized execution of clinical trials in accordance with the approved Study Plan.Holding responsibility for implementing and following up operational processes and tools to ensure effective clinical trial management. Holding responsibility for staffing and efficient resource utilization, training and personnel development.Ensuring the development of staff including professional development, performance appraisals, and employee counseling.Depending on the number of direct reports and other duties assigned, the CRM might in addition take over CTM activities.All tasks must be conducted in accordance with applicable Company Policies, Guidelines, Standard Operating Procedures (SOPs), Working Instructions (WIs), and other Guidance and Standards, as well as current Good Clinical Practice (ICH-GCP) and applicable national regulations.
EDUCATION/ LANGUAGESDegree in life sciences (e.g. biology, chemistry, pharmaceutics) or medicine, advanced degree preferredCertification in clinical research (US: ACRP or other certification), or bachelor or master degree in clinical research/clinical trial management highly desirableExcellent command of English language (verbally and in writing); other language(s) as appropriate for location PROFESSIONAL SKILLS & EXPERIENCEAt least 5 years clinical trial management experienceAltogether 8 years experience in clinical research in CRO or Pharmaceutical/Biotechnology Industry environmentIn-depth understanding of clinical development processesProfound experience in all aspects of clinical trial planning and start up (including budget & resource planning), and in executing the complete range of clinical trial activities, from start up through final study reportExcellent understanding of the roles and responsibilities of all relevant functions involved in a clinical trial (e.g. biostatistics, data management, drug safety, CRO, etc.)Experience in collaboration with and supervision of CROs, including multinational trialsExcellent knowledge of ICH-GCP, other relevant Guidance documents (from ICH, FDA, EMEA etc.), and of regulations and requirements for clinical trial authorization in major countriesExperience in leading teams in a matrix or line roleProject management skills and process improvement skillsProficient IT skills (including MS Word, Excel, Power Point, e-mail, clinical application systems) PERSONAL SKILLS & COMPETENCIESAble to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful mannerExcellent time management skillsWilling and able to take on responsibilityAbility to foster a team environmentThinks beyond the confines of own function; considers interfaces, understands need for and actively fosters cross-functional cooperationStrong leadership skills, able to lead and manage teams and to direct, influence and motivate people; this includes assigning reasonable tasks and working packages, setting priorities, and tracking of timely delivery and qualityHighly self-motivated and proactiveOpen-mindedStrong interpersonal skillsStrong written and verbal communication skills; able to communicate effectively with internal and external contact personsExcellent presentation skillsAdvanced negotiation skillsAdvanced conflict management skillsAnalytical skills, quick perception and excellent judgment; able to identify risks and problems, to develop adequate problem solving strategies even in complex situations, and to take appropriate measures when requiredAbility to anticipate and avert problems before they impact adversely on a projectAble to coach and train othersStrategic thinking beyond own function; is familiar with and takes into account overall business objectives and company strategyAble to work independentlyAble to cope with high workload when necessaryFlexibility and willingness to take on and lead special tasks and projects as assigned