At Datacubed Health, we are transforming the clinical trial experience for participants in biotech and contributing to innovation in the life sciences & pharmaceutical industry. We incorporate the principles of behavioral neuroeconomics to engage participants as citizen scientists, who adhere to the study protocols and are proud of their contributions to curing diseases. Designed for decentralized, virtual trials, Datacubed Health’s disruptive mHealth platform, Linkt, uses behavioral science and SaaS technology to improve patient compliance, retention, and increase data quality.
Datacubed Health is seeking a highly motivated, driven, and goal-oriented Director of Project Management to lead and oversee the execution of clinical projects and research studies in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies. Project Management Directors direct and manage the team responsible for clinical delivery of complex; global full service, multi-regional studies and/or programs. They will have strategic decision-making responsibility for the project/programs and be responsible for direction and management of portfolios and/or accounts from an operational perspective ensuring that studies and/or programs are delivered on time and quality resulting in strong financial performance and customer satisfaction and in accordance with SOPs; policies and practices from pre-award to close-out. They will serve as a liaison with Business Development and Bids/Contracts for the client presentations, bid defenses and proposal development. This candidate will play an integral role in client onboarding, team management, escalations, quality, compliance and orchestration of and prioritization of resources. The candidate will work closely with clinical operations, digital technologists, and clinical innovators, program managers, and research coordinators. The position will report to the Chief Operating Officer.
The qualified candidate can think critically, operating within a growth corporate culture, act quickly, communicate effectively at all levels and bring with them a willingness to offer extra assistance across departments.
We offer a competitive salary and benefits. Compensation will be commensurate with experience (see requirements below).
Key Duties and Job Responsibilities of the Project Manager:
To be successful, you will bring an excellent entrepreneurial mindset and be flexible, adapting to changing priorities in a fast-paced environment. You will be expected to keep knowledge and information flowing seamlessly and to periodically present to executive leadership, foster relationships, and develop key business/operational skills to drive project and institutional success. Essential to your success, will be your ability to win team members’ respect and to proactively anticipate client requests and manage solutions by understanding project dependencies and stakeholder relationships as it relates to the projects you work on, as well as ensure timely and effective communication with other team members. In this role, you shall additionally have the duties, responsibilities and authority that are consistent with and normally associated with such a position, including, but not limited to the following:
o Contribute to the development of the project delivery strategy for Request for Proposals (RFPs). Participate in bid defense preparations.
o Participate in bid defense presentations in partnership with business development for large, complex, multi-service, multi-region studies or programs.
o Understand and be able to present project strategy and operationalize the agreed upon approach in a manner appreciated by life sciences and pharmaceutical clientele.
o Forecast and identify opportunities to accelerate activities to bring revenue forward.
Project Operations and Implementation
o Oversee the development of integrated study management plans with the core project team.
o Direct the execution of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
o Recognize systemic issues at program or portfolio level and identify solutions with the project teams, recommend actions to improve efficiencies and oversee the implementation of best practices, address escalation items with the customer.
o Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
o Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
o Responsible for the management and delivery of large and/or complex studies or programs of studies.
o May be responsible for portfolio management with one customer or therapeutic area.
o Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
o Serve as escalation point of contact with customer and own relationship with key customer contact(s), communicate/collaborate with DATACUBED business development as necessary.
o Drive consistency of operational delivery across customer’s projects/programs/portfolio.
o Identify changes in scope and manage change control process as necessary, identify opportunities to increase scope to assist the Customer's business needs.
o Identify and communicate strategic lessons learned and best practices to promote continuous improvement.
o Communicates with sponsor(s) regularly to obtain direction and feedback on implementing scope of work as well as performance to date. Identifies unusual or significant problems encountered during the course of a clinical trial and proposes strategies for preventing or correcting significant problems.
o Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
o Build the cross-functional project/program/portfolio team and lead their efforts, responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
o Participate in, champion and adopt function and/or corporate initiatives, changes and/or special project assignments, act as a client liaison, departmental cross-functional liaison and/or change coach.
o Provide input to line managers of their project team members’ performance relative to project tasks.
o Recommend team members’ further professional development.
o Support staff development.
o Mentor less experienced project team members on assigned projects to support their professional development.
o Create/manage onboarding and training for new PMs around the project implementation life cycle and product configuration
Knowledge of Clinical Trials
- Experience in clinical research, including a full-service project management experience
- Previous experience in clinical research (Phase I-IV studies), ideally within the pharmaceutical industry
- Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements, i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct
- Broad protocol knowledge, therapeutic knowledge desired
- Knowledge of medical therapeutic area and medical terminology.
Communications & Management
- Strong oral and written communication skills with the ability to clearly and effectively present to the target audience, including illustrating protocol and study workflows using programs like LucidChart, and developing PowerPoint presentations.
- Planning, time management and prioritization skills
- Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances
- Ability to prioritize work across multiple projects
- Attention to detail and accuracy in work.
- Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
- Ability to work across geographies displaying high awareness and understanding of cultural differences
- Effectively recruits, inducts and retains staff.
- Effective critical-thinking and problem-solving skills to assist in detecting potential issues and issue resolution.
- Demonstrate an ability to exercise discretion, good independent judgment, and independent thinking in selecting the optimal course of action.
- Results-oriented approach to work delivery and output. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
- The ability to proficiently use project management tools, such as Smartsheet, Jira, Box, Word processing and Spreadsheet applications.
- Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint
- Familiarity with Agile development methodology
- Previous experience with SaaS products, eCOA, Telemedicine, eConsent and other similar software solutions.
- Certifications such as PMI, Six Sigma are a plus.
- Requires 12 years of prior relevant experience including minimum 8 years of project management or relevant functional experience OR equivalent combination of education, training and experience
- Solid understanding of a project life cycle methodology, strong judgment, and excellent project management skills
- Travel of 25% is estimated for this position. Exact amounts of travel will vary, pending client needs.
- Ability to demonstrate all DATACUBED competencies (Transparency, Accountability, Community Centric, and Curiosity).
Given the civic mission of the company and project, it is especially important that employees uphold the business’ principles honestly and ethically; strive to improve the quality of our services, products, and operations and maintain a reputation for privacy, honesty, fairness, respect, responsibility, integrity, philanthropy, trust, innovation, exploration and sound judgment; and adhere to high standards of business and personal integrity as a representation of our business practice.
Datacubed Health is a pioneer in developing an engaging patient experience for decentralized clinicial trials using behavioral science paired with mobile healthcare technologies for remote data collection, flexible tracking and analytics, and scientifically driven study and technology designs to promote high clinical trial compliance. The Linkt Platform allows our partners to engage with our mobile or web solutions, incorporating tools such as virtual visits, geofencing, or medication adherence, to collect high quality data, and allow users across study roles access to the information they need to unlock the mysteries of what it means to be human. This is a great organization with a collaborative growth culture and a common goal: to get “Better Data based on Better Science, yielding Better Analysis and Better Policy.” We're a talented bunch of people seeking to unlock our human code, showing the connectedness to the physical world, unveiling all of the factors that make humans...human, and unleash the intrinsic value in doing so. Datacubed Health world headquarter is located in Brooklyn, New York. Visit us online at www.datacubed.com.
Datacubed Health is an equal opportunity employer.