Sr. Clinical Trial Manager

You are not just a number to us; you are a talented individual with the potential to impact the future of global health. So we take this unique approach to the talent we partner with, which is why people choose our high-quality service time and time again.

Our Pharma and Biotech team knows the Clinical Trial Manager vacancies and the Clinical Trial Manager companies that need your credentials. So, if you're looking for a contract CTM job within this space, then we can help. Get in touch with our team today to discover more.

The Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs. The position reports to the Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This position will focus on rare disease, but in the future may work across programs and studies within Therapeutics.

Key Responsibilities:

Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trial
Lead the Clinical Trial Team, and support other development teams as a Clinical Operations representative as required
Perform and document study level Sponsor Oversight of outsourced clinical activities
Communicate study-status, cost, and issues to ensure timely decision-making by senior management
Initiate and manage study-level timelines, including communication to internal and external team members on deliverables
Work closely with other supporting clinical operations team members, if applicable, to execute clinical studies
Draft and/or oversee the drafting of site materials including training, manuals and support documentation
Review clinical data to ensure timely entry and readiness for data review meetings
Perform periodic review of clinical data, quality metrics and study deviations
Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Review clinical monitoring reports to ensure timely completion and identification of issues
Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
Complete and maintain internal clinical trial metrics, dashboards and other internal updates
Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials
Participate in testing of clinical trial systems/databases (i.e. UAT)
Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
May support additional clinical trial(s) in various capacities (e.g., unblinded clinical trial manager, regional clinical trial manager, etc.)
Participate in clinical operations workstreams related to departmental and operating model related initiatives Develop and maintain strong, collaborative relationships with key stakeholders within and external to our Client.
Strive for continuous improvement and more efficient ways of working in clinical development
Act as a role model for our Client’s values

Requirements:

5-7 years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent trial management preferred
Experience with early phase complex global trials required. Rare disease experience required. Diverse trial experience across phases and multiple therapeutic areas desirable (oncology, autoimmune/ immune mediated, cardiovascular).
Bachelor’s degree required; Advanced degree preferred
Relevant experience in global setting, across more than one phase of development, and across entire lifecycle of a study
Solid understanding of drug development
Good project management skills
Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
Excellent verbal and written communication skills
Good organizational skills and attention to detail

We are pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Generous paid time off, including vacation, sick time and holidays
401k match and Financial Planning tools

Contact:

Please contact at saad@medina-sk.com or +1-470-354-4005 if you would like to learn more about this opportunity.

CRA II / Sr. CRA

Our Pharma and Biotech team knows the Clinical Research Associate vacancies and the Clinical Research Associates companies that need your credentials. So, if you're looking for a contract CRA job within this space, then we can help. Get in touch with our team today to discover more.

Are you passionate about advancing healthcare and making a difference in the world?
Join our dynamic team as a Senior Clinical Research Associate (SCRA), where you will play a pivotal role in guiding small to medium biopharmaceutical companies through the intricate landscape of clinical trials, ultimately bringing life-changing therapies to patients globally.

Location: Hybrid/Remote*

As a SCRA, you will independently manage and monitor investigation sites, proactively identify and resolve issues, and ensure clinical studies are conducted according to protocols and compliance standards. You will be the essential link between project teams and site staff, ensuring the smooth and efficient conduct of clinical trials.

Key Responsibilities:

Govern quality standards for trial monitoring activities.
Conduct Selection, Initiation, Monitoring, and Closure Visits at Investigator Sites as per project schedule.
Monitor clinical study sites to ensure adherence to GCP, ICH, SOPs, and study protocols.
Track and supervise the collection of ongoing study data for regular project status reporting.
Collect and review regulatory documents as required.
Prepare site visit and telephone contact reports.
Maintain and update CTMS in compliance with SOPs and study-specific directives.
Act as Document Owner for collected documents.
Participate in study start-up processes, including preparing Informed Consent forms, developing study documents, and managing site contracts.
Resolve site issues and ensure smooth communication between the project team and site staff.
Collaborate with the Centralized Monitoring Team to evaluate risk-based monitoring activities.
Identify and address logistical and practical problems, supporting the project team in creating solutions and contingency plans.
Ensure continuous maintenance of the Trial Master File and Investigator Site File.
Assist the Project Manager and Clinical Team Leader in generating study-specific forms and following up for timely completion and submission.
Support the start-up team or sponsor in obtaining authorization of regulatory documents and site contracts.
Attend and organize Investigator Meetings and study-specific training sessions.
Participate in feasibility and site identification activities as needed.
Prepare and attend Assessment Visits with senior CRA, CTL, or Clinical Research Manager.
Process interim and final payments to Investigators.
Provide in-house review of CRFs and support site staff in preparing for audits and inspections.
Report quality issues and support root cause analysis and corrective actions.
Contribute to country-specific, GCO, and CTO initiatives for improvements and quality enhancement.
Manage multiple projects and tasks independently and as part of a team.

Requirements:

At least three years of clinical monitoring or relevant clinical trial experience.
Relevant life science degree, healthcare, nursing background, or related degree.
Strong knowledge of medical terminology and clinical monitoring processes.
Excellent communication skills in both Local and English languages, written and verbal.
Strong interpersonal and organizational skills.
Ability to translate guidelines, rules, and regulations into clear recommendations.
Client-focused, representative, and outgoing personality.
Ability to thrive in a fast-paced and challenging environment.
In-depth therapeutic and protocol knowledge.
Willingness to travel up to 8 days per month, depending on project needs.
Proficiency with computer applications such as Word, Excel, and PowerPoint.
Demonstrated ability to manage multiple projects and mentor colleagues.
Attention to detail and administrative excellence.

We are pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Generous paid time off, including vacation, sick time and holidays
401k match and Financial Planning tools

*Our Client’s hybrid work policy encourages a dynamic work environment, requiring 2 days in the office per week for employees within reasonable distance from one of our locations.

Contact:

Please contact at saad@medina-sk.com or +1-470-354-4005 if you would like to learn more about this opportunity.

Medical Director - Pharma Advertising - Remote

Job Title: Medical Director
Location: West Chester, PA (Remote)

Meet the Client:

MEDINA-SK has partnered with a top client on their search for a sharp Medical Director to join and lead their ever-growing team! This agency is independently owned and full-service, specializing in both Pharma Advertising + Medical Communications. The team boasts a client roster of blue-chip pharma's + emerging biotech's and are proud to offer their clients a full-service agency capability whist executing an unparalleled, boutique agency service.

As MD, you will be the lead and oversight of your designated accounts leading content development efforts. If you are looking to take your career to the next level, whilst working in a dynamic work environment with a great team where your career can thrive and grow - Apply below or reach out directly to learn more.

Key Responsibilities:

Provide scientific direction, support, and leadership for all strategic and tactical communications activities for assigned therapeutic areas and products
Develop clinical content for branded and unbranded medical and promotional communications tactics and activities, including hands-on writing and annotation of content for HCP and patient educational material/brochures, videos, websites, and other multimedia initiatives
Daily point of contact for clients, building confidence in the agencies service and ensuring a high level of scientific and strategic partnership
Act as the leading provision of scientific input with clients and accounts, working with the team(s) across both accounts, to ensure that client communication strategies are understood and actioned by scientific, editorial and account teams
Support new business development and assist and encourage organic growth of existing accounts by identifying gaps in services or product offering to existing clients and accounts
Remain up-to-date with emerging market trends and upkeep a thorough understanding and expertise of assigned therapeutic landscapes
Provide mentorship/guidance, support, and feedback to junior medical team members, copywriters, and freelance contract writers as needed during the content development process

Requirements:

A higher education degree - PhD, MD, PharmD - required
A minimum of 3 years' working within the Pharmaceutical Advertising space, patient experience is ideal.
Excellent communication skills, verbal and written
Ability to interact effectively across boundaries using influencing and relationship building skills
Strong problem-solving capabilities with the ability to prioritize and make tradeoffs to achieve goals

Contact:

Please contact at saad@medina-sk.com or +1-470-354-4005 if you would like to learn more about this opportunity.