Release Manager

Bioclinica, Inc Princeton , NJ 08544

Posted 2 months ago

Primary Responsibilities

Manage all aspects of OnPoint CTMS customer relationships post-implementation

  • Full responsibility for the management of all customer relationships from the hand-off from the "implementation" Project Manager until discontinuation of each customer's use on OnPoint

  • Participates in implementations of OnPoint from project kickoff until hand-off to ensure that support project management has a strong understanding of customer's deployment requirements and the details of each customer's OnPoint deployment

  • Complete responsibility for first level customer support for CTMS system; responsible for the resolution of all customer issues, and the escalation of customer issues which are not resolved at first level and managing them until resolution, in accordance with contractual Service Level Agreements

  • Providing excellent customer service at all times during all interactions with customers

  • Directly responsible for all post-implementation customer training on system

  • Interfacing with development on behalf of the customer during product delivery lifecycle to ensure customer expectations are met in final product

  • Management of customer's product version upgrades and training on product version new features

  • Work with other onsite BioClinica personnel to ensure maximum compatibility between all BioClinica systems on-site

Maintains Quality Service and Departmental Standards by

  • Contributing to the development and maintenance of the CTMS product roadmap resulting in the production of new features or enhancements to existing products with product management

  • Reading, understanding and adhering to organizational Standard Operating Procedures ("SOP")

  • Establishing and enforcing departmental standards

  • Reviewing and updating company SOPs related to CTMS / Project Management Services

Secondary Responsibilities

Contributes to team effort by

  • Exploring new opportunities to add value to organization and departmental processes

  • Helping other Project Managers to accomplish deliverables

  • Performing other duties as assigned and deemed necessary

Maintains Technical Knowledge by

  • Attending and participating in applicable company sponsored training

Qualifications:

Education:

  • Bachelor's degree preferred; Associate's degree required

Experience:

  • 3+ years experience in software or technical product management

  • Working knowledge of software delivery lifecycle and methodology

  • Clinical trials experience within a CRO or pharmaceutical research organization in a project management related position preferred

Additional skill set:

  • Excellent customer service skills

  • Ability to function in a multi-task environment with a positive attitude under pressure.

  • Strong interpersonal and communication skills, both verbal and written

  • Strong organizational and leadership skills

  • Goal oriented

Working conditions:

Travel: 0-25%

Lifting: 0-20lbs

Other: Computer work for long periods of time


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manager Scientific Affairs (Product Development)

Novartis Pharmaceuticals

Posted Yesterday

VIEW JOBS 4/8/2020 12:00:00 AM 2020-07-07T00:00 $500 million! That's the savings Sandoz has provided in just two years to the US healthcare system as a result of the successful adoption of one of our oncology supportive care biosimilar into clinical practice. Sandoz has eight biosimilar approved globally - including four in the US - and more than ten in the pipeline. Biosimilar may enable more patients to access advanced biologic medicines earlier, and Sandoz has proven that biosimilar offer significant savings for overburdened health systems. We are looking for curious, innovative, driven people to help us get these products into the market. Maybe that's you. Manager, Product Development (Scientific Affairs) Job Purpose Under the direction of the Head of Scientific Affairs, the Manager, Product Development is responsible for supporting the Scientific Affairs Department with expertise in formulation and scale-up/process development and devices of pharmaceutical products/assets (hard to make generics, complex generics and differentiated therapeutics) being considered for in-licensing, co-development as well as driving select projects as project leader. This includes working directly with a cross-functional team across Business Development and Licensing (BD&L), Regulatory Affairs (RA), Quality Assurance (QA) and Medical Office/Clinical Development (CD) to evaluate CMC aspects of new product acquisition and in-license opportunities, using their own knowledge and experience. As CMC expert with the ability to effectively collaborate cross-functionally (across CMC, clinical, regulatory, Portfolio and commercial team) conceive innovative product designs and globally drive in-house development work from ideation to Proof-of-Concept. The Manager, Product Development must be able to process various sources of information and data provided by the target company, through site visits, and public resources, into a concise report of the risks and potential benefits of the opportunity. The Manager, Product Development communicates needs and outcomes to Scientific Affairs and BD&L leadership and owns responsibility for the content, quality and on-time delivery of the assigned product evaluations. Major Accountabilities * Participates as a core member of the Due Diligence (DD) team from kick-off through close-out, to evaluate mainly ANDA (505j) and select NDA (505b2) opportunities with a CMC sub-team. * Product Development Lead (pre-close out) on Pre-Due Diligence, Due Diligence (DD) teams from kick-off through close-out, to evaluate target opportunities with a CMC sub-team, looking for risks and opportunities in the area of API and Finished Product characterization/evaluation which could impact the successful development, filing and commercialization of the target asset. * Product Development Lead (post close-out) to oversee, and guide external product development initiatives for the development of 505j and 505(b)(2) products. These products include those that are developed at third party site and require a Sandoz representative to oversee partnership product development based on scientific principles and regulatory requirements appropriate to Sandoz's values and behaviors, corporate compliance, speed-to-market philosophy, and organizational excellence. As a scientific expert, lead opportunities related to due diligences for in-licensing or acquisition of products and related assets (dossiers, technology, etc.). This includes a thorough review and understanding of the offered products' characteristics and performance based on quality attributes, robustness of formulation and manufacturing processes, and life cycle of the asset. * Understand and apply Quality by Design (QbD) principles during the different stages of product development, including review of drug product characterization, raw material quality attributes, drug-device compatibility, design of experiments, stability testing, product / process optimization, and statistical evaluation of data. * Prepares DD reports to summarize the findings into a concise evaluation of possible risks and opportunities, and a prioritized, actionable plan and mitigation strategy. * Seeks input from other functional area Subject Matter Experts (SMEs) to build teams with the appropriate expertise as required to perform target evaluations, while maintaining confidentiality requirements of due diligence. * Provides timely updates to the Global ESD (Early Stage Development), US Scientific Affairs and BD&L leadership. * Represents Sandoz to the target companies in a professional and competent manner, supporting our value proposition as the "partner of choice" to potential partner companies. * When needed works with IP Legal to assess potential CMC IP opportunities. * PhD or Masters' degree in Chemistry, Pharmaceutical Sciences or closely related field. PhD preferred. * Generally has at least 7 years' experience in the Pharmaceutical Industry with development and scale-up of complex dosage forms including parenteral dosage forms and CMC aspects from product development thru commercialization is preferred. * Business development and Due Diligence experience for Complex Generics (505j) as defined by FDA guidance is desired. * Drug-device combination product experience is desired * Drug-device combination product experience is desired. * Recognized expertise in a specific area and related areas. Broad scientific as well as strategic background. * Excellent track record of innovation, creativity, problem solving and productivity in projects * Travel requirements up to 20%. Novartis Pharmaceuticals Princeton NJ

Release Manager

Bioclinica, Inc