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| Job #02496 |
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| About our client |
| Our client is the biotech division of a world leading healthcare company that has developed a reputation for successfully bringing complex products to market in a variety of therapeutic areas. With an experienced clinical team and empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate! |
| Position |
Location |
| Clinical Research Organization Manager |
New Jersey |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Oversee Contract Research Organization relationships and contracts 2) Determine the best short/long-term strategies for CRO utilization for Phase I to Phase IV clinical trials or other services 3) Research and assess CRO capabilities and manage the RFP process to optimize selection of CROs 4) Negotiate contract terms relative to timelines, resources and quality 5) Drive CRO performance/accountability through project plans, status reports, metrics and scorecards 6) Provide direction and oversee in all facets of the CRO business relationship, including conflicts, issue resolution, project status and adherence to budget |
| Requirements |
1) Master’s degree in Science with strong business acumen or equivalent training and experience 2) MBA would be a plus 3) 5 years of clinical development experience (as senior CRA or CPM) in a pharmaceutical or medical device industry 4) 3+ years of CRO management experience as Senior CRA/CPM 5) Direct CRO management related experience a plus 6) Experience in developing clinical research strategies within the pharmaceutical industry and delivering results through to successful implementation 7) Experience overseeing CROs for clinical studies in the pharmaceutical or medical device industry 8) Detailed understanding of clinical development process and understanding of clinical trial management 9) Solid understanding of cost drivers for clinical trials as related to contracts and cost reduction 10) Familiarity with regulatory requirements for third party research organizations 11) Strong leadership skills with an ability to utilize organizational channels 12) Experience and influencing skills in facilitating successful project implementation, stakeholder management and effective issue resolution inside and outside of company 13) Ability to build, cultivate and maintain strong working relationships with external vendors 14) Knowledge of financial and accounting practices 15) Excellent leadership, management, project management and analytical skills 16) Strong interpersonal, planning, communication and collaboration skills necessary 17) Sound decision-making and problem-solving capabilities 18) Strong negotiation skills 19) Willingness to travel – up to 25% |

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