Advanced Clinical Hiring For Clinical Project Manager at Woburn, MA  Full Time

OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team out of Woburn, Massachusetts as a Clinical Project Manager. This remote position is responsible for the planning, implementation, and conduct of single region or less complex, clinical trials in Phase I-III. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Manage or assist in managing study execution including management and oversight of CROs, vendors, and consultants
• Establish study milestones and ensure accurate tracking/reporting of study metrics and timelines
• Identify risks, offer mitigation strategies, and support implementation
• Ensure trial adherence to ICH-GCP, Federal and local regulations, and company specific SOPs
• Oversee investigator recruitment/ selection across project
• Participate in ad hoc clinical operations’ initiatives and programs
• Prepare and review clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates
• Contribute to the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, project management plans, communication plans, and quality plans
• Direct clinical monitoring to ensure that all outstanding site issues are closed out in a timely manner
• Partake in the forecasting of Investigational Medicinal Product and clinical trial related supplies
• Track study progress ensuring timely data collection, monitoring, and in collaboration with data management, internal listings reviews
• Verify that the Trial Master File (TMF) is set up and maintained throughout the trial in compliance with ICH/GCP and company SOPs
• Support with the development of the clinical components of regulatory submissions including, but not limited to safety, interim, and final study reports
• Participate/aid with responding to Quality Assurance audits and regulatory authority inspections
• Assist with ongoing study communication and escalation of study-related issues
• Participate in meetings with investigator sites, key opinion leaders, and consultants
• Facilitate the development of clinical trial agreements and other relevant documents
• Contribute to request, creation, and review of scope of work and budgets
• Partake in vendor performance management and issue resolution
• Review and provide input for site budgets
• Manage clinical trial budget and provide ongoing financial reporting/projections to finance
• Reconcile and report for vendor and site invoices, payments and change orders, ensuring accuracy and timely delivery
• Work cross-functionally to ensure clinical program timelines and goals are met
• Conduct site visits, evaluating CROs/contract monitors through co-monitoring visits and/or site audits
• Provide study-specific mentoring for junior team members
• Participate in operational improvement initiatives

EXPERIENCE

• Minimum of 5 years of experience in clinical research with at least 2 years of experience in study management required
• Clinical Monitoring experience preferred
• Experience in management of CROs, vendors, and consultants
• Documented training, knowledge, and application of current FDA Regulations, ICH-GCP guidelines for clinical trials required
• Proficient written and verbal communication skills
• Ability to collaborate effectively with the study team, cross-functional team members, and external partners (including investigator and site staff) using collaborative negotiation skills
• Therapeutic (oncology) or medical knowledge preferred
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook, and MS Project
• Position may require some travel

EDUCATION

• Minimum of Bachelor’s Degree in health sciences or related field required

To be a best-fit your strengths must include:

• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
• Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.